[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Henlius Biotech\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":549},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,41,64,86,106,128,148,172,192,215,236,257,278,298,322,343,361,379,399,421,444,464,484,508,529],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100629365","phase-1-a-phase-i-clinical-study-to-evaluate-the-safety-tolerability-and-pk-of-hlx48-in-advancedmetastatic-solid-tumors-100629365",false,"NCT07473726","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in Advanced\u002FMetastatic Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX48 (EGFR\u002Fc-MET Bispecific Antibody-Drug Conjugate) in Participants With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;\n2. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;\n3. Participants with histologically or cytologically confirmed advanced\u002Fmetastatic malignant solid tumors, who have failed or have no available standard treatment;\n4. At least one measurable lesion as per RECIST v1.1 within 4 weeks prior to the first dose;\n5. An ECOG performance status score of 0-1 within 7 days prior to the first dose;\n6. Expected survival \\> 3 months;\n7. The following conditions should be met in terms of the time of the first dose of the investigational product: at least 28 days (or 5 half-lives of the drug, whichever is shorter) from the previous major surgery, medical device treatment, locoregional radiotherapy (except for palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biological product therapy; at least 14 days from the previous small molecule targeted drug therapy, hormone therapy, or administration of the traditional Chinese medicine for anti-tumor indications; at least 7 days from paracentesis and other minor surgery; recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v6.0, except for alopecia, well-controlled abnormal thyroid function and type 1 diabetes mellitus);\n8. Availability of archival tumor tissue specimen (from the most recent surgery or biopsy, preferably within 2 years) meeting assay requirements, or agreement to undergo biopsy for tumor tissue collection for assessment of EGFR and c-MET protein expression;\n9. Adequate organ function as confirmed by laboratory tests within 7 days prior to the first dose of the investigational product (no blood transfusions or treatment with granulocyte colony-stimulating factor within 14 days prior to the first dose);\n10. For participants with hepatocellular carcinoma, Child-Pugh score must be A;\n11. Male and female participants with reproductive potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female participants of childbearing potential must receive pregnancy test within 7 days prior to enrollment to rule out pregnancy.\n\nExclusion Criteria:\n\n1. History of other malignant tumors within 2 years prior to first dose, except radically treated early-stage malignant tumors (carcinoma in situ or stage I tumors), such as cured cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;\n2. History of serious ocular diseases, including: (1) keratoconjunctivitis sicca; (2) severe keratopathy; (3) moderate or severe xerophthalmia;\n3. History of (non-infectious) interstitial lung disease (ILD) requiring use of steroids, or current ILD, or suspected ILD that cannot be ruled out by imaging at screening;\n4. Known history of severe allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies, or allergy to any component in the formulation of the investigational product; previous exposure to ADCs with topoisomerase I inhibitors as payload;\n5. Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first dose of the investigational product;\n6. Patients who have received systemic corticosteroids (prednisone \\> 10 mg\u002Fd or equivalent dose of similar drug) or other immunosuppressants within 2 weeks prior to randomization; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term prophylactic use of corticosteroids for contrast agents, etc.;\n7. Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg after active treatment); (6) pericarditis or uncontrolled pericardial effusion; (7) myocarditis;\n8. Assessed as unsuitable for inclusion by the investigator, due to newly developed or clinically symptomatic brain or meningeal metastases, spinal cord compression, or cancerous meningitis, or uncontrolled brain or spinal cord metastases that have been evidenced;\n9. Participants with known active or suspected autoimmune diseases. Participants with autoimmune-related hypothyroidism who are receiving thyroid hormone replacement therapy and those with type 1 diabetes mellitus controlled with insulin therapy are eligible to be enrolled;\n10. Presence of unhealed skin lesions, including but not limited to (1) major traumatic injury within 4 weeks prior to the first dose (for paracentesis and other minor surgery, the investigator must confirm that the skin has healed prior to the first dose); (2) planned major surgery during treatment with the investigational product or within 6 months after the last dose;\n11. Presence of uncontrollable pleural effusion or pericardial effusion after appropriate intervention, or ascites requiring repeated drainage (once a month or more frequently);\n12. Use of strong inhibitors or inducers of CYP3A within 2 weeks prior to the first dose;\n13. Patients with active tuberculosis;\n14. Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or a history of organ transplantation;\n15. Patients with active HBV or HCV infection or HBV\u002FHCV co-infection;\n16. Pregnant or lactating women;\n17. Participants who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.","ALL","18 Years","75 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX48 in patients with advanced\u002Fmetastatic solid tumors.",[28],"Advanced\u002FMetastatic Solid Tumors","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":30,"type":33},{"date":36,"type":22},"2028-08",{"name":38,"class":39},"Shanghai Henlius Biotech","INDUSTRY",7,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100613683","phase-2-a-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-hlx43--serplulimab-as-neoadjuvant-therapy-in-subjects-with-nsclc-100613683","NCT07269782","A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC","A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC","Inclusion Criteria:\n\n* 1\\. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;\n* 2\\. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;\n* 3\\. Histologically or cytologically confirmed NSCLC;\n* 4\\. Diagnosed with stage II-IIIB NSCLC (according to the Union for International Cancer Control and the American Joint Committee on Cancer (AJCC) TNM staging system for lung cancer (8th edition)), without actionable genomic alterations (AGAs); subjects with non-squamous NSCLC must have previous test results confirming negative EGFR and ALK gene alterations, and if no previous EGFR and ALK test results are available, the subjects are required to undergo relevant tests at the study site; for subjects with squamous NSCLC, if the previous EGFR and\u002For ALK gene status is unknown, corresponding tests are not required before enrollment in this study;\n* 5\\. Agree to undergo surgery if eligible after neoadjuvant therapy; prior to study enrollment, the subject should be assessed by the primary thoracic surgeon, who holds the main responsibility for the surgery, to confirm eligibility for R0 resection with curative intent as required by the study; the subject must have good cardiac function and be confirmed as eligible for surgical resection with curative intent;\n* 6\\. At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to randomization;\n* 7\\. Subjects who agree to provide archived tumor tissue specimens that meet the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissue for PD-L1 expression testing; Note: Formalin-fixed paraffin-embedded (FFPE) tumor samples (paraffin blocks or unstained sections, which must meet the quality control criteria for testing) from the most recent surgery or biopsy at or after the diagnosis of malignant tumor and pathological reports of such specimens should be provided by subjects.\n* 8\\. The following conditions must be met in terms of the time of the first administration of the investigational product: at least 3 weeks from the previous major surgery or medical device treatment; at least 1 week from the previous minor surgery; recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v5.0);\n* 9\\. ECOG PS score of 0-1 within one week prior to randomization;\n* 10\\. Life expectancy \\> 3 months;\n* 11\\. Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization (no blood transfusions or treatment with albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) within 14 days prior to the first dose)；\n* 12\\. Male and female subjects with childbearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female subjects of childbearing age must be negative for pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n* 1\\. Histologically or cytologically confirmed tumor containing components of small cell lung cancer or neuroendocrine carcinoma;\n* 2\\. Any prior systemic or local anti-tumor therapy for non-small cell lung cancer, including chemotherapy, radiotherapy, or immunotherapy;\n* 3\\. History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;\n* 4\\. History of adverse events leading to permanent discontinuation of immunotherapy, or history of ≥ Grade 2 immune-related pneumonitis or immune-related myocarditis;\n* 5\\. Subjects with current or prior history of clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to the first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, interstitial pneumonitis, pneumoconiosis, drug-related pneumonitis, and pleural effusion), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within 6 months;\n* 6\\. Patients with any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc interval ≥ 470 ms) (QTc interval is calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg after active treatment);\n* 7\\. Patients with active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to randomization;\n* 8\\. Patients who have previously received other antibodies\u002Fdrugs against immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.;\n* 9\\. Patients who have used moderate or potent CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization;\n* 10\\. Patients who have received systemic corticosteroids (prednisone \\> 10 mg\u002Fd or equivalent dose of similar drug) or other immunosuppressants within 2 weeks prior to randomization; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term prophylactic use of corticosteroids for contrast agents, etc.;\n* 11\\. Patients with known active or suspected autoimmune diseases. Patients with autoimmune-related hypothyroidism and receiving thyroid hormone replacement therapy and those with type 1 diabetes mellitus controlled with insulin therapy are eligible to be enrolled;\n* 12\\. Patients who have received a live vaccine or live attenuated vaccine within 4 weeks prior to randomization;\n* 13\\. Patients who are known to have anaphylaxis to macromolecular protein preparations\u002Fmonoclonal antibodies or are allergic to any component in the formulation of the investigational product;\n* 14\\. Patients with active tuberculosis;\n* 15\\. Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or history of organ transplantation;\n* 16\\. Patients with active HBV or HCV infection or HBV\u002FHCV co-infection; Note: Patients who test positive for HBsAg or HBcAb during the screening period must undergo further HBV-DNA testing, and may be enrolled only if the test result indicates \\\u003C 500 IU\u002FmL, \\\u003C 2500 copies\u002FmL, or \\\u003C ULN. Patients with detectable HBV-DNA must agree to receive treatment with anti-HBV nucleos(t)ide analogs during the study.\n\nPatients who test positive for HCV antibody must undergo further HCV-RNA testing, and may be enrolled only if the test result indicates \\\u003C ULN.\n\nPatients with HBV\u002FHCV co-infection (positive test for HBsAg or HBcAb and positive test for HCV antibody) should be excluded.\n\n* 17\\. Pregnant or lactating women;\n* 18\\. Patients who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.",{"count":49,"type":22},60,[51],"PHASE2","The study is being conducted to to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant Therapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)",[54],"Non Small Cell Lung Cancer","2026-06-02",{"date":57,"type":33},"2026-06-04",{"date":59,"type":33},"2026-01-20",{"date":61,"type":22},"2026-11-30",{"name":38,"class":39},1,{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":63},"100628293","phase-2-a-global-phase-iiiii-clinical-study-to-evaluate-the-efficacy-and-safety-of-hlx43-monotherapy-or-hlx43-in-combination-with-hlx07-versus-docetaxel-in-advanced-or-metastatic-squamous-non-small-cell-lung-cancer-100628293","NCT07459751","A Global Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","A Randomized, Open-Label, Multi-center, Global Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) Monotherapy or HLX43 in Combination With HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;\n2. Aged ≥ 18 years at the time of signing the ICF, male or female;\n3. Histologically or cytologically confirmed squamous NSCLC, locally advanced (stage IIIB\u002FIIIC) or metastatic (stage IV) NSCLC not suitable for radical treatment (complete surgical resection, concurrent\u002Fsequential radio-chemotherapy) according to the Union for International Cancer Control and the American Joint Committee on Cancer (AJCC) TNM staging system (8th edition);\n4. Subjects must have progressed after platinum-based chemotherapy in combination with anti-PD-1\u002Fanti-PD-L1 therapy as the only prior first-line treatment or progressed after platinum-based chemotherapy followed by anti-PD-1\u002Fanti-PD-L1 therapy (in any order) as the only prior second-line treatment.\n\nNote: Definition of prior treatment failure with platinum-based chemotherapy:\n\n1. Progressive disease following platinum-based chemotherapy in the recurrent or metastatic setting;\n2. Progressive disease or recurrence during platinum-based chemotherapy, or within 6 months after the end of platinum-based chemotherapy in the neoadjuvant chemotherapy, concurrent radio-chemotherapy, or adjuvant chemotherapy setting;\n3. Intolerance to platinum-based chemotherapy; 5. At least one measurable lesion as per RECIST v1.1 within 4 weeks prior to randomization; Note: Measurable target lesions should not be selected from previous radiotherapy sites or brain lesions. A measurable lesion within the field of local radiotherapy can be selected as the target lesion only when it is the only optional target lesion and the imaging evidence before and after progression should be available.\n\n6\\. Subjects who agree to provide archived tumor tissue specimens that meet the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissues for PD-L1 and EGFR expression testing; Note: Formalin-fixed paraffin-embedded (FFPE) tumor samples (paraffin blocks or unstained sections, which must meet the quality control criteria for testing) collected from non-radiotherapy sites during the most recent surgery or biopsy at or after the diagnosis of malignant tumor and pathological reports of such specimens shall also be provided.\n\n7\\. The following conditions must be met in terms of the time of the first administration of the investigational product: at least 3 weeks (or 5 half-lives of the drug, whichever is shorter) from the previous major surgery, medical device treatment, locoregional radiotherapy (except for palliative radiotherapy for bone lesions), cytotoxic chemotherapy, or immunotherapy; at least 1 week from the administration of the traditional Chinese medicine for anti-cancer indications or minor surgery; and recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v5.0, except for Grade 2 peripheral neurotoxicity and alopecia); 8. ECOG PS score of 0-1 within 1 week prior to randomization; 9. Life expectancy \\> 3 months; 10. Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization (no blood transfusions or treatment with granulocyte colony-stimulating factor within 14 days prior to the first dose); 11. Male and female subjects with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female subjects of childbearing age must be negative for pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed tumor containing components of small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma;\n2. Prior treatment with any medication targeting topoisomerase I, including chemotherapy or ADCs;\n3. Prior treatment with docetaxel;\n4. Radical radiation therapy within 3 months prior to the first dose;\n5. History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;\n6. History of ≥ Grade 3 irAEs in immunotherapy;\n7. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n8. Presence of spinal cord compression or clinically active metastases to central nervous system (referring to untreated or symptomatic metastases, or metastases requiring corticosteroids or anticonvulsants to control associated symptoms), carcinomatous meningitis. Subjects who have previously received treatment for brain metastases (such as whole brain radiotherapy or stereotactic brain radiotherapy) may be eligible, provided that they are clinically stable for at least 4 weeks with no imaging evidence of brain metastasis progression;\n9. Subjects with current and prior history of clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to: any underlying lung disease (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, interstitial pneumonia, pneumoconiosis, and drug-related pneumonitis within 3 months prior to the first dose), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, and sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within 6 months;\n10. Patients with any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to:\n\n(1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc interval ≥ 470 ms) (QTc interval is calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg after active treatment); 11. Patients with active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to randomization; 12. Patients who have used moderate or potent CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization; 13. Patients who have received systemic corticosteroids (prednisone \\> 10 mg\u002Fd or equivalent dose of similar drug) or other immunosuppressants within 2 weeks prior to randomization; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term prophylactic use of corticosteroids for contrast agents, etc.; 14. Patients with known active or suspected autoimmune diseases. Patients with autoimmune-related hypothyroidism and receiving thyroid hormone replacement therapy and those with type 1 diabetes mellitus controlled with insulin therapy are eligible to be enrolled; 15. Patients who have received live vaccine or live attenuated vaccine within 4 weeks prior to randomization; 16. Patients who are known to have anaphylaxis to macromolecular protein preparations\u002Fmonoclonal antibodies or are allergic to any component in the formulation of the investigational product; 17. Patients with active tuberculosis; 18. Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or history of organ transplantation; 19. Patients with active HBV or HCV infection or HBV\u002FHCV co-infection; Note: Patients who test positive for HBsAg or HBcAb during screening must further undergo HBV-DNA testing. If the test result suggests \\\u003C 500 IU\u002FmL, \\\u003C 2500 copies\u002FmL, or \\\u003C ULN, the patient can be enrolled. Patients with HBV-DNA detected must agree to receive treatment with anti-HBV nucleos(t)ide analogues during the study.\n\nPatients who test positive for HCV antibody must further undergo HCV-RNA testing. If the test result suggests \\\u003C ULN, the patient can be enrolled.\n\nPatients with HBV\u002FHCV co-infection (positive for HBsAg or HBcAb and positive for HCV antibody) must be excluded.\n\n20\\. Pregnant or lactating women; 21. Patients who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.",{"count":72,"type":22},706,[51,74],"PHASE3","This is a randomized, open-label, multi-center, global phase II\u002FIII clinical study to evaluate the efficacy and safety of HLX43 monotherapy or HLX43 in combination with HLX07 vs. docetaxel in the treatment of advanced squamous NSCLC after failure of first-line treatment.",[77],"Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","2026-05-28",{"date":80,"type":33},"2026-06-01",{"date":82,"type":33},"2026-05-27",{"date":84,"type":22},"2030-01-15",{"name":38,"class":39},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100634580","phase-1-a-phase-i-clinical-study-of-hlx316-in-participants-with-advancedmetastatic-solid-tumors-100634580","NCT07541534","A Phase I Clinical Study of HLX316 in Participants With Advanced\u002FMetastatic Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX316 (B7-H3 Targeting Sialidase Fc Fusion Protein) in Participants With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Fully understand the contents, process and possible adverse reactions of the study before the study, sign the informed consent form, voluntarily participate in the study, and be able to complete the study according to the requirements of the study protocol;\n2. Aged ≥ 18 years at the time of signing ICF;\n3. Participants with histologically or cytologically confirmed advanced or metastatic solid tumors who have failed at least one line of standard systemic therapy in the advanced or metastatic setting (participants who received neoadjuvant or adjuvant therapy and experienced progressive disease or relapse within 6 months after completion of such therapy will be considered to have failed one line of standard therapy), or for whom no effective standard therapy is available, or who are intolerant of or refuse standard systemic therapy;\n4. At least 1 measurable lesion per RECIST v1.1 within 4 weeks prior to the first dose; for participants who have received prior radiotherapy, a previously irradiated lesion may be considered a target lesion if it is measurable per RECIST v1.1 and there is objective evidence of significant progression following radiotherapy; brain metastatic lesions may not serve as target lesions;\n5. ECOG performance status of 0 or 1 within 7 days prior to the first dose;\n6. Expected survival of more than 3 months;\n7. At least 28 days must have elapsed between the first dose of investigational drug and any prior major surgical procedure, medical device treatment, local radiotherapy (except palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biologic therapy; at least 14 days must have elapsed since prior small-molecule targeted therapy or hormonal therapy; at least 7 days must have elapsed since prior traditional Chinese medicine with antitumor indications or minor surgery; and any treatment-related AEs must have recovered to CTCAE v6.0 Grade ≤ 1 (except alopecia);\n8. The participant agrees to provide archival tumor tissue specimen sufficient to meet testing requirements (from the most recent surgery or biopsy, preferably within 3 years) or agrees to undergo a fresh biopsy for tumor tissue collection (unless the investigator determines that the procedure would pose an unacceptable risk to the participant's safety), for assessment of tumor sialylation and protein expression including B7-H3; Note: Participants are required to provide a formalin-fixed, paraffin-embedded (FFPE) tumor sample (paraffin block or unstained sections, meeting quality control standards for testing) collected from a non-irradiated site at the time of or after the diagnosis of malignancy, from the most recent surgery or biopsy, along with the corresponding pathology report for the above specimen.\n9. Adequate organ function confirmed by laboratory assessments performed within 7 days prior to the first dose of study drug (without receipt of transfusions, granulocyte colony-stimulating factors, or thrombopoietic agents within 14 days prior to the first dose):\n\n   Hematologic System Absolute neutrophil count (ANC) ≥ 1.0 × 109\u002FL Platelet count (PLT) ≥ 75 × 109\u002FL Hemoglobin (Hb) ≥ 90 g\u002FL Liver Function Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), unless a known genetic cause of elevated bilirubin is present (e.g., Gilbert's syndrome) Alanine aminotransferase (ALT) ≤ ULN; ≤ 2.5 × ULN for participants with hepatic metastases or hepatocellular carcinoma Aspartate aminotransferase (AST) ≤ ULN; ≤ 2.5 × ULN for participants with hepatic metastases or hepatocellular carcinoma Renal Function Creatinine (Cr) ≤ 1.5 × ULN; if \\> 1.5 × ULN, creatinine clearance must be ≥ 40 mL\u002Fmin (calculated using the Cockcroft-Gault formula) Coagulation Function (unless the participant is receiving anticoagulant therapy) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN Prothrombin time (PT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN\n10. Male and female participants of childbearing potential must agree to use at least 1 highly effective method of contraception during the study and for at least 6 months after the last dose of investigational drug; female participants of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n11. The tumor type for participants with advanced solid tumors may be any of the following:\n\n    * Platinum-resistant ovarian cancer\n    * Other advanced\u002Fmetastatic solid tumors with B7-H3 expression confirmed by IHC.\n12. Participants with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer must also meet all of the following criteria:\n\n    * Histologically or pathologically confirmed epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer, with no evidence of non-epithelial carcinoma, borderline tumor, mucinous carcinoma (or seromucinous carcinoma with a predominant mucinous component), malignant Brenner tumor, or undifferentiated carcinoma.\n    * Participants must have received at least 2 prior lines of therapy for metastatic ovarian cancer, including at least 1 platinum-based regimen, or must be intolerant to such standard treatments.\n    * Must be platinum-resistant, defined as progressive disease confirmed by CA-125, clinical, or imaging assessment within 6 months after the last platinum-containing chemotherapy regimen.\n\nExclusion Criteria:\n\n1. History of arterial thromboembolic events, stroke, or transient ischemic attack within the past 12 months.\n2. History of symptomatic chronic heart failure (New York Heart Association \\[NYHA\\] Class II-IV or left ventricular ejection fraction \\[LVEF\\] \\\u003C 50%) or history of arrhythmia requiring treatment (including QTc interval ≥ 450 ms in males or ≥ 470 ms in females) (QTc interval calculated using the Fridericia formula).\n3. History of myocardial infarction or unstable angina within 6 months prior to the first dose of HLX316.\n4. Evidence of active infection requiring intravenous antibiotic therapy during the screening period, or evidence of active infection requiring treatment within 7 days prior to the first dose of HLX316.\n5. Active uncontrolled bleeding or bleeding tendency within 7 days prior to HLX316 administration.\n6. Serious or non-healing wounds, fistulas, skin ulcers, or non-healing fractures within 7 days prior to HLX316 administration.\n7. The participant has previously participated in this study.\n8. The participant is currently participating in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.\n9. Receipt of any other therapy within 3 weeks or 5 half-lives prior to HLX316 administration, whichever is shorter.\n10. Known infection with human immunodeficiency virus (HIV) (any HIV seropositivity or detectable human immunodeficiency virus type 1 ribonucleic acid \\[HIV RNA\\]).\n11. Active syphilis infection, defined as positive serological test result that has not been adequately treated.\n12. Active hepatitis B or hepatitis C infection. Participants with well-controlled hepatitis B virus\u002Fhepatitis C virus (HBV\u002FHCV) infection may be eligible if the following criteria are met and after discussion with the Medical Monitor (MM):\n\n    Hepatitis B:\n    * Hepatitis B surface antigen (HBsAg)-positive (chronic HBV infection): participants are eligible if they are receiving antiviral therapy and hepatitis B virus deoxyribonucleic acid (HBV DNA) is controlled\u002Fundetectable.\n    * HBsAg-negative and anti-hepatitis B core (HBc)-positive (resolved prior infection): eligible for enrollment. Prophylactic treatment should be considered and reactivation should be monitored.\n\n    Hepatitis C\n    * Prior HCV infection that has been successfully cured (ribonucleic acid \\[RNA\\] undetectable).\n    * HCV Ab-positive but RNA-negative (spontaneous clearance).\n13. Participants with untreated central nervous system (CNS) epidural tumors or metastases, or untreated brain metastases. Known leptomeningeal metastases, or uncontrolled or symptomatic central nervous system (CNS) metastases, manifesting as clinical symptoms, cerebral edema, spinal cord compression, and\u002For progressive growth. Participants with a history of CNS metastases or spinal cord compression may be enrolled if they have received definitive treatment and are considered clinically stable by the investigator after discontinuation of anticonvulsants and steroids for 8 weeks prior to initiation of study treatment. Participants with untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no requirement for corticosteroids, no brain metastatic lesion with a longest diameter \\> 1.5 cm, and no significant edema peripheral to brain metastatic lesions) may be enrolled. Brain metastatic lesions will not be designated as target lesions.\n14. Participants with current or prior autoimmune disease requiring systemic immunosuppressive therapy (including, but not limited to, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis, hemolytic anemia, Sjögren's syndrome, and sarcoidosis).\n15. Current requirement for systemic corticosteroids or use of systemic corticosteroids within 4 weeks prior to enrollment (inhaled corticosteroids are permitted for participants with asthma or chronic obstructive pulmonary disease, as are other non-systemic steroids such as topically administered corticosteroids).\n16. In the investigator's judgment, the participant has other serious illnesses that make participation in this study inappropriate.\n17. Participant is unwilling or unable to follow protocol requirements.\n18. Other primary malignancy within 3 years prior to enrollment that has not been treated with curative intent (the investigator may consider discussion with the Medical Monitor), excluding non-metastatic basal cell\u002Fsquamous cell carcinoma of the skin or non-muscle-invasive bladder cancer.\n19. Any condition that, in the investigator's judgment, may interfere with the evaluation of the investigational drug, participant safety, or interpretation of study results.",{"count":94,"type":22},41,[25],"This study is an open-label, first-in-human Phase I clinical study to evaluate the safety, tolerability, PK characteristics, and preliminary antitumor activity of HLX316 in participants with advanced\u002Fmetastatic solid tumors. The study will consist of 2 parts: a Phase Ia dose-escalation part and a Phase Ib dose-expansion part. Phase Ia and Phase Ib will focus on exploring the preliminary antitumor activity of HLX316 in participants with platinum-resistant ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.",[28],"2026-05-25",{"date":78,"type":33},{"date":101,"type":33},"2026-05-22",{"date":103,"type":22},"2029-06-01",{"name":38,"class":39},5,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100629662","phase-1-a-study-to-compare-the-pk-characteristics-safety-tolerability-and-immunogenicity-of-hlx15-sc-with-darzalex-faspro-in-combination-with-lenalidomide-and-dexamethasone-rd-in-transplant-ineligible-patients-with-newly-diagnosed-multiple-myeloma-100629662","NCT07477587","A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma","A Randomized, Double-blind, Parallel-controlled Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of signing the informed consent form (ICF).\n2. Body mass index (BMI): 18.5 kg\u002Fm2 ≤ BMI \\\u003C 28 kg\u002Fm2.\n3. Subjects must participate voluntarily, understand the study, and sign the ICF.\n4. Patients must have a documented diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) criteria, with measurable lesion .\n5. Serum albumin ≥ 35 g\u002FL.\n6. Newly diagnosed, untreated, and considered ineligible for high-dose chemotherapy with autologous stem cell transplantation (ASCT) by the investigator.\n7. The patient's ECOG performance status must be 0 or 1 .\n8. Patient must have clinical laboratory values meeting the following criteria during the screening period:\n\n   1. Hemoglobin ≥ 7.5 g\u002FdL (≥ 5 mmol\u002FL; red blood cell \\[RBC\\] transfusion or use of recombinant human erythropoietin at least 1 week prior to randomization is allowed).\n   2. Absolute neutrophil count (ANC) ≥ 1.0 × 109\u002FL (use of granulocyte-colony stimulating factor \\[G-CSF\\] is allowed).\n   3. Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).\n   4. Without the following evidence of impaired liver function, including mild impairment (total bilirubin ≤ ULN and AST \\> ULN or ULN \\\u003C total bilirubin ≤ 1.5 x ULN), moderate impairment (1.5 x ULN \\\u003C total bilirubin ≤ 3 x ULN), and severe impairment (total bilirubin \\> 3 x ULN).\n   5. Measured creatinine clearance ≥ 40 mL\u002Fmin .\n   6. Corrected serum calcium \\\u003C 14 mg\u002FdL (\\\u003C 3.5 mmol\u002FL); or free ionized calcium \\\u003C 6.5 mg\u002FdL (\\\u003C 1.6 mmol\u002FL) .\n   7. Platelet count ≥ 70 × 109\u002FL for patients with plasma cells \\\u003C 50% of bone marrow nucleated cells; platelet count \\> 50 × 109\u002FL for all other patients (transfusion within 3 days prior to randomization to achieve the minimum platelet count is not permitted).\n9. Contraceptive criteria: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n   1. Female patients: a female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n      Not a woman of childbearing potential (WOCBP) or WOCBP: must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously from signed ICF to at least 140 days following the last dose of study products. This includes one highly effective contraceptive method with a failure rate of \\\u003C 1% per year (tubal ligation, intrauterine device, hormonal \\[birth control pills, injections, hormonal patches, vaginal rings or implants\\] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy.\n\n      The subjects also need to agree not to donate or cryopreservation eggs (ova, oocytes) from signed ICF to at least 140 days following the last dose of study products.\n   2. Male patients: male patients are eligible to participate if they agree to the following during the intervention period and for at least 140 days following the last dose of study products:\n\n   Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.\n\n   or Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year as when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.\n\n   Agree not to donate or cryopreservation sperm.\n10. A WOCBP must have a negative serum pregnancy test at screening within 72 h prior to randomization. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy\n\nExclusion Criteria:\n\n1. Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.\n2. Patient has plasma cell leukemia (according to IMWG criterion: ≥ 5% of plasma cells in the peripheral blood and\u002For an absolute plasma cell count of ≥ 2 x 109\u002FL) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).\n3. Patient has prior or current systemic therapy or ASCT for MM, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg\u002Fday for a maximum 4 days) of corticosteroids before randomization.\n4. Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.\n5. Patient has a history of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence within 3 years).\n6. Patient has clinical signs of meningeal involvement of MM.\n7. Patient has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second \\[FEV1\\] \\\u003C 50% of predicted normal), persistent asthma, or a history of asthma within the last 2 years. Patient with known or suspected COPD or asthma must have a FEV1 test during screening.\n8. Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP).\n9. Patient is known to have active hepatitis B or C.\n\n   1. Patient is seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]). Patients with resolved infection (that is, patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[Anti-HBc\\] and\u002For antibodies to hepatitis B surface antigen \\[Anti-HBs\\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded.\n\n      EXCEPTION: Patients with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.\n   2. Patient is seropositive for hepatitis C must be screened using PCR measurement of hepatitis C virus (HCV) ribonucleic acid (RNA) levels. Those who are PCR positive will be excluded.\n10. Patient has any concurrent medical or psychiatric condition or disease (e.g., active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.\n11. Patient has clinically significant cardiac disease, including:\n\n    1. Myocardial infarction within 1 year before randomization, or an unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association \\[NYHA\\] Class III-IV ).\n    2. Cardiac arrhythmia (NCI-CTCAE Version 6 Grade ≥ 2) or clinically significant ECG abnormalities.\n    3. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) (See Appendix 6) \\> 470 ms.\n12. Patient has known allergies, hypersensitivity, or intolerance to lenalidomide, corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products.\n13. Patient has history of drug abuse or substance abuse one year prior to randomization. Patient is known or suspected of not being able to comply with the study protocol (e.g., because of alcoholism, drug dependency, or psychological disorder).\n14. Patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes) while enrolled in this study or within 140 days after the last dose of study products.\n\n    Or patient is a man who plans to father a child and\u002For donate sperm while enrolled in this study or within 140 days after the last dose of study products.\n\n    Patient does not agree to abstain completely from sexual intercourse, or plan to use a contraceptive method that is not acceptable to the investigator (unacceptable methods of contraception include: i. periodic abstinence \\[such as calendar method, ovulation method, basal body temperature method, post-ovulation safety period method, etc.\\], withdrawal, etc.; ii. medical contraceptive measures such as oral contraceptives, contraceptive injections, contraceptive patches, subcutaneous implantation, intrauterine hormone contraceptive devices, local contraceptives such as spermicides, etc.).\n15. Patient had radiation therapy within 14 days of randomization.\n16. Patient had plasmapheresis within 28 days of randomization.\n17. Patient had a history of blood donation or total blood loss of 200 mL or more within 3 months before randomization.\n18. Patient had major surgery within 28 days before randomization or has not fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 28 days after the last dose of study treatment. Kyphoplasty is not considered major surgery.\n19. Patient in clinical trials of any other drug or device within 3 months (or 5 half-lives of the corresponding investigational product if the half-life of the drug is long \\[5 half-lives \\> 3 months\\]) before randomization.\n20. Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments",{"count":114,"type":22},258,[25],"The purpose of this study is to compare the pharmacokinetic (PK) similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC versus US-DARZALEX FASPRO® following single and multiple subcutaneous (SC) injections in newly diagnosed MM patients ineligible for transplant.\n\nParticipants who meet all inclusion criteria and none of the exclusion criteria will receive either the HLX15-SC-Rd regimen or the D-Rd regimen for 4 cycles (one cycle = 4 weeks). After 4 cycles of treatment, based on clinical benefit and participant preference, participants may continue to receive the locally marketed daratumumab subcutaneous formulation (Dara-SC) in combination with Rd according to clinical practice, up to 32 weeks or until loss of clinical benefit, death, unacceptable toxicity, withdrawal of informed consent, or any other protocol-specified reason, whichever occurs first. After 32 weeks of dosing, participants will continue to receive appropriate standard of care according to local guidelines (including marketed Dara-SC).",[118],"Multiple Myeloma (MM)",[120],"Transplant ineligible Patients with Newly Diagnosed Multiple Myeloma","2026-05-19",{"date":101,"type":33},{"date":82,"type":22},{"date":125,"type":22},"2028-02-22",{"name":38,"class":39},81,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100637806","phase-1-a-study-to-evaluate-the-pharmacokinetics-efficacy-and-safety-of-hlx319-vs-eu-phesgo-in-the-neoadjuvant-therapy-of-her2-positive-early-or-locally-advanced-breast-cancer-100637806","NCT07601620","A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer","A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Phesgo® Biosimilar HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer","Inclusion Criteria:\n\n* Voluntary participation in the clinical study and signed the Informed Consent Form (ICF).\n* Male or female aged ≥ 18 years old at the time of signing the ICF;\n* Histologically confirmed invasive breast cancer, stage II-IIIC, Human Epidermal Growth Factor Receptor 2 (HER2) positive confirmed by central laboratory.\n* Participants agree to undergo surgery while meeting the criteria for surgery after neoadjuvant therapy.\n* Left ventricular ejection fraction (LVEF) at baseline ≥ 55%.\n* An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.\n* Adequate major organ functions.\n* Women with child-bearing potential have a negative result of serum pregnancy test at screening period (within 7 days prior to the first dose) or if they are infertile, non- lactating, reproduction-age men and women following highly effective contraceptive measures until 7 months after last dose.\n\nExclusion Criteria:\n\n* Stage IV breast cancer, bilateral breast cancer, or multicentric breast cancer.\n* History of other malignancy within 5 years.\n* Prior systemic therapy for breast cancer treatment or radiotherapy.\n* Patients with a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) who have received systemic therapy or radiotherapy to the ipsilateral breast.\n* Patients who have undergone excision biopsy of the primary tumor and\u002For axillary lymph nodes or lymph node dissection.\n* Have severe heart disease or medical conditions.\n* Participants with viral hepatitis or those with autoimmune hepatitis, sclerosing cholangitis, or liver cirrhosis.\n* Human Immunodeficiency Virus (HIV) infection, HIV antibody positive.\n* Daily use of corticosteroid treatment is required.\n* Sensitivity to any study medications or any of its ingredients or excipients.\n* Participants who underwent any major surgery within 28 days prior to the first dose. Or participants who have received local radiotherapy, radiofrequency ablation, or interventional therapy within 2 weeks prior to the first dose.\n* Received another interventional clinical trial therapy within 4 weeks prior to enrollment in the study, or intentionally participated in another interventional clinical trial during the entire study period.\n* Severe, uncontrolled systemic diseases that may currently interfere with the therapeutic plan.\n* Any other conditions which are inappropriate for the study in the opinion of the investigator.",{"count":114,"type":22},[25],"This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .",[139],"HER2 + Breast Cancer","NOT_YET_RECRUITING","2026-05-15",{"date":101,"type":33},{"date":144,"type":22},"2026-07-03",{"date":146,"type":22},"2027-07-22",{"name":38,"class":39},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100605270","phase-1-a-phase-i-clinical-study-to-evaluate-the-pk-profile-efficacy-safety-and-immunogenicity-of-hlx17-vs-keytruda-in-multiple-resected-solid-tumors-100605270","NCT07160335","A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors","A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® (US-sourced Keytruda®) in Multiple Resected Solid Tumors","Inclusion Criteria:\n\n1. Participants must have signed and dated an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC) approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines.\n2. At least 18 years and no older than 85 years (including 85 years old) at the time of signing the ICF.\n3. 18 kg\u002Fm2 ≤ body mass index (BMI) ≤ 30 kg\u002Fm2 and 50 kg ≤ body weight ≤ 85 kg.\n4. The patient with one of the following resected solid tumors:\n\n   * NSCLC patients after complete resection OR\n   * Melanoma following complete resection OR\n   * Renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.\n5. Have a performance status of 0 on the Eastern Cooperative Oncology Group (ECOG) Performance Status within 7 days prior to the first dose in this study.\n6. Have a life expectancy of at least 12 weeks.\n7. Have adequate organ function as indicated by the following laboratory values (no blood transfusions, or treatment with albumin, recombinant human thrombopoietin or colony-stimulating factor within 14 days prior to the first dose in this study)\n8. Female patients must meet one of the following conditions:\n\n   1. Menopause (defined as no menstruation for at least 1 year with no confirmed cause other than menopause), or\n   2. Surgically sterilized (removal of the ovaries and\u002For uterus), or\n   3. Fertile, but must:\n\n      * be tested negative for serum\u002Furine pregnancy test within 7 days prior to the randomization, and\n      * agree to use contraception methods with an annual failure rate of \\\u003C 1% or to remain abstinent (avoid heterosexual intercourse from signing the ICF to at least 6 months after the last dose of the study drug) (a contraceptive method with an annual failure rate of \\\u003C 1% includes bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that can inhibit ovulation, hormone-releasing intrauterine devices and copper-containing intrauterine devices or condoms), and\n      * not breastfeed\n9. Male patients must: agree to remain abstinent (avoid heterosexual intercourse) or take contraception measures as follows: male patients with a pregnant partner or a partner of childbearing potential must remain abstinent or use condoms to prevent drug exposure to the embryo during study treatment and for at least 6 months after the last dose of study drug. Periodic abstinence (e.g., contraception based on calendar day, ovulatory phase, basal body temperature, or postovulatory phase) and external ejaculation are ineligible methods of contraception.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. History of illicit drug use or alcohol abuse within 12 months prior to randomization in the investigator's judgment.\n3. Participants with NSCLC have two synchronous primary non-small cell lung cancers or other histopathological types (such as mixed adenosquamous carcinoma, small cell lung cancer, or neuroendocrine carcinoma)； known positive for EGFR sensitive mutations or ALK fusion. EGFR sensitive mutations include: exon 19 deletion mutation (19DEL) and exon 21 point mutation (21L858R).\n4. Participants with MEL have mucosal or ocular melanoma.\n5. Participants with RCC have pre-existing brain or bone metastatic lesions, or residual thrombus in the renal vein or vena cava after nephrectomy.\n6. Participants with other primary active malignancies within 5 years or at the same time prior to randomization.\n7. Have received an organ or bone marrow transplantation prior to randomization or scheduled for transplantation during the study.\n8. Presence of central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n9. Symptomatic cerebrovascular disease or known myocardial infarction or poorly controlled arrhythmia (including QTcF intervals ≥ 450 ms for males and ≥ 470 ms for females calculated by Fridericia's formula) within 6 months prior to randomization.\n10. Chronic heart failure (Class III to IV based on NYHA classification) or an LVEF (left ventricular ejection fraction) assessed with the doppler echocardiography less than 50%.\n11. Peripheral neuropathy greater than or equal to Grade 2 (CTCAE).\n12. Known human immunodeficiency virus (HIV) infection (or positive anti-HIV during screening), or known Hepatitis B (or positive test for HBsAg or HBcAb and positive test for HBV-DNA during screening), or known Hepatitis C (or positive tests for HCV antibody and HCV-RNA during screening), or known Hepatitis B and C co-infection (or positive test for HBsAg or HBcAb and positive test for HCV antibody during screening), or active pulmonary tuberculosis within 6 months prior to randomization.\n13. Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity prior to screening.\n14. Known severe allergic or anaphylactic reactions to pembrolizumab or any other monoclonal antibody or any components of the investigational medicinal products.\n15. Known active or suspected autoimmune diseases. Patients with stable disease who do not require systemic immunosuppressive therapy may also participate.\n16. Unstable hyperthyroidism or hypothyroidism at screening.\n17. Have received live vaccines within 28 days prior to the first dose in this study (Inactivated viral vaccines for seasonal influenza are allowed).\n18. Treatment with systemic corticosteroids (\\> 10 mg\u002Fday prednisone efficacy dosage) or other immunosuppressive drugs within 14 days prior to the first dose or during the study. However, participants are allowed to be enrolled under the following conditions: in the absence of active autoimmune disease, participants are allowed to use topical or inhaled steroids and adrenal hormone replacement therapy at dosages equivalent to ≤ 10 mg\u002Fday of prednisone efficacy.\n19. Any active infection requiring systemic therapy within 1 month prior to the first dose in this study.\n20. Participants have planning to undergo surgical treatment during this clinical trial. Tumor puncture or incisional lymph node biopsy is allowed.\n21. Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before randomization.\n22. Participants have participated in a clinical study with another investigational medicinal product prior to randomization, and the interval between the current study and the previous study is too short: within 1 month prior to the first dose of the current study or within 5 half-lives of the previous investigational medicinal product (whichever is longer). Or planning to participate in a clinical study with another investigational medicinal product before completing all scheduled assessments in this clinical study.\n23. Participants have participated in a device clinical study within 1 month prior to screening, or are participating in another surgical or device clinical study at the time of screening, or plan to participate in another surgical or device clinical study during this clinical study.\n24. The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.","85 Years",{"count":157,"type":22},174,[25],"This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety, and immunogenicity of HLX17 vs. US-sourced Keytruda® in patients with resected non-small cell lung cancer (NSCLC) or melanoma (MEL), or renal cell carcinoma (RCC).",[161,162,163],"Non-small Cell Lung Cancer","Melanoma","Renal Cell Carcinoma","2026-05-14",{"date":141,"type":33},{"date":167,"type":33},"2025-09-26",{"date":169,"type":22},"2028-03-27",{"name":38,"class":39},69,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":63},"100575194","phase-2-a-phase-ii-clinical-study-to-evaluate-hlx43-in-patients-with-recurrentmetastatic-escc-failed-or-intolerance-to-standard-therapy-100575194","NCT06769113","A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent\u002FMetastatic ESCC Failed or Intolerance to Standard Therapy","A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent\u002FMetastatic Esophageal Squamous Cell Carcinoma (ESCC) Failed or Intolerance to Standard First-line Therapy","Inclusion Criteria:\n\n1. Volunteer to participate in clinical research; To fully understand and understand this study and to sign the Informed Consent Form (ICF); Willing to follow and able to complete all test procedures;\n2. The age of signing ICF is ≥ 18 years old and ≤ 75 years old;\n3. Esophageal Squamous Cell Carcinoma (ESCC) confirmed by histopathology or cytology;\n4. Patients with advanced esophageal squamous cell carcinoma who have failed or are intolerant to prior first-line standard therapy (for patients with PD-L1 expression positive \\[CPS ≥1\\], first-line standard therapy is defined as platinum-based chemotherapy and immune checkpoint inhibitor \\[ICI\\] therapy; for patients with PD-L1 expression negative \\[CPS \\\u003C1\\], first-line standard therapy is defined as platinum-based chemotherapy). Intolerable toxicity refers to the occurrence of CTCAE grade ≥3 adverse events.;\n5. Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST v1.1 criteria;\n6. Tumor tissue should be provided as much as possible for an evaluable PD-L1 expression result at Screening period；\n7. Before the initial administration of the study drug, there should be at least a 3-week interval or 5 times the half-life of the last cytotoxic chemotherapy, immunotherapy, or biological therapy, whichever is shorter. There should be at least a 2-week interval from the previous small molecule targeted therapy, at least a 1-week interval from traditional Chinese medicine treatment with antitumor indications or minor surgery. Additionally, treatment-related adverse events (AEs) should have recovered to NCI-CTCAE grade ≤ 1 (except for grade 2 peripheral neurotoxicity and alopecia)；\n8. The ECOG physical performance score of 0-1 in the week prior to randomization；\n9. Expected survival ≥ 3 monthes；\n10. Laboratory tests within the previous week confirm adequate organ function (within 14 days prior to the first dose of medication, without receiving interventions such as blood transfusions, granulocyte colony-stimulating factor, or recombinant human thrombopoietin)；\n11. Male and female subjects of childbearing potential must agree to use at least one highly effective method of contraception during the trial and for at least 6 months after the last dose of the study drug. Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n1. History of any second malignant tumor within the first 2 years prior to randomization;\n2. BMI \\\u003C17.5 kg\u002Fm2；\n3. Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases;\n4. After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently;\n5. A history of ≥ grade 3 radiation pneumonia; A history of (non-infectious) interstitial lung disease (ILD) requiring steroid use, or a current ILD, or suspected ILD cannot be ruled out by imaging at the time of screening; Or there are lung diseases leading to clinical severe respiratory impairment;\n6. Subjects exhibit poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure, or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) unstable angina; (3) myocardial infarction or cerebrovascular accident within the last 6 months (excluding lacunar infarction, minor ischemic stroke, or transient ischemic attack); (4) uncontrolled arrhythmias (including QTc interval ≥ 450 ms for males, ≥ 470 ms for females) (QTc interval calculated by Fridericia's formula); (5) poorly controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg despite active treatment);\n7. Subjects who are preparing for or have previously received an organ or bone marrow transplant;\n8. Within the 2 weeks prior to randomization, there is the presence of an active systemic infectious disease requiring intravenous antibiotic treatment;\n9. Used strong inhibitors or strong inducers of CYP2D6 or CYP3A within 2 weeks prior to randomization;\n10. Received systemic corticosteroids (prednisone \\>10 mg\u002Fday or an equivalent dose of similar drugs) or other immunosuppressive treatments within 14 days prior to the first dose; with the following exceptions: use of topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylactic treatment during situations such as the use of contrast agents;\n11. History of adverse events leading to permanent discontinuation of immunotherapy; or a history of grade 2 or higher immune-related pneumonitis or myocarditis;\n12. Active or suspected autoimmune disease. Patients with autoimmune-related hypothyroidism who are undergoing thyroid hormone replacement therapy are permitted to participate in the study; patients with controlled Type 1 diabetes mellitus receiving insulin therapy are also allowed to participate in the study;\n13. Live vaccinations or attenuated live vaccinations should not be administered within 4 weeks prior to the initial dosing. Administration of inactivated viral vaccines for seasonal influenza is permitted;\n14. Known history of severe allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies, or allergy to components of the trial drug formulation；previous treatment with antibody-drug conjugates (ADCs) using a topoisomerase I inhibitor as the payload;\n15. Active tuberculosis;\n16. Human immunodeficiency virus (HIV) infection;\n17. Pregnant or lactating women;\n18. The researcher deems that the subject has any other factors that make them unsuitable for participation in this trial.",{"count":180,"type":22},102,[51],"The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent\u002FMetastatic Esophageal Squamous Cell Carcinomar (ESCC) Failed or Intolerance to Standard First-Line Therapy.",[184],"Esophageal Cancer",{"date":186,"type":33},"2026-05-18",{"date":188,"type":33},"2025-01-26",{"date":190,"type":22},"2027-06-05",{"name":38,"class":39},{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100624981","phase-1-a-phase-i-clinical-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-hlx3901-in-patients-with-advanced-sclc-or-nec-100624981","NCT07416695","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 (DLL3 × DLL3 × CD3 × CD28 Tetra-specific Antibody) in Patients With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma","Inclusion Criteria:\n\n1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;\n2. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;\n3. Histologically or cytologically confirmed advanced small cell lung cancer or neuroendocrine carcinoma; patients with advanced small cell lung cancer must have experienced intolerance, recurrence, or disease progression following prior treatment with a platinum-based therapy combined with immune checkpoint inhibitors, while patients with neuroendocrine carcinoma must have experienced intolerance, recurrence, or disease progression following prior platinum-based therapy; allowed histological subtypes include combined small cell lung cancer and mixed neuroendocrine-non-neuroendocrine neoplasms.\n4. At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to the first administration;\n5. An ECOG performance status score of 0-1 within 7 days prior to the first administration;\n6. Expected survival \\> 3 months;\n7. The following conditions must be met in terms of the time of the first administration of the investigational product: at least 28 days from the previous major surgery, medical device treatment, locoregional radiotherapy (except for palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biological product therapy; at least 14 days from the previous small molecule targeted drug therapy and previous hormone therapy; at least 7 days from the previous administration of the traditional Chinese medicine for anti-tumor indications or minor surgery; recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v6.0, except for alopecia);\n8. Participants who agree to provide archived tumor tissue specimens that meet the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissue for DLL3 expression testing; Note: Formalin-fixed paraffin-embedded (FFPE) tumor samples (paraffin blocks or unstained sections, which must meet the quality control criteria for testing) collected from non-radiotherapy sites during the most recent surgery or biopsy at or after the diagnosis of malignant tumor and pathological reports of such specimens shall also be provided.\n9. Adequate organ function as confirmed by laboratory tests within 7 days prior to the first administration of the investigational product, with no therapies such as blood transfusion, albumin infusion, renal replacement therapy, granulocyte colony-stimulating factor (G-CSF), thrombopoietin, or erythropoietin administered within 14 days prior to the first administration:\n10. Male and female participants with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female participants of childbearing age must be negative for pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n1. History of other malignant tumors within 2 years prior to the first administration, except cured cervical carcinoma in situ or cutaneous basal cell carcinoma;\n2. Presence of Grade ≥ 2 immune-related pneumonitis or immune-related myocarditis, or severe, life-threatening immune-mediated AEs or infusion-related reactions, including those leading to permanent discontinuation, when receiving previous anti-tumor immunotherapy;\n3. History or presence of clinically significant pulmonary impairment due to concurrent lung disease, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to the first administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, and pleural effusion), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sicca syndrome, and sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within the past 6 months;\n4. With central nervous system diseases within 12 months prior to enrollment, such as seizures, cerebral hemorrhage, paralysis, aphasia, cerebral infarction (except for old cerebral infarction), severe brain injury, dementia, Parkinson's disease, cerebellar disease, mental illness, or any autoimmune disease involving the central nervous system;\n5. Active paraneoplastic syndrome;\n6. History of hypophysitis or pituitary dysfunction;\n7. Presence of uncontrolled third-space effusions (e.g., massive pleural effusion, ascites, or pericardial effusion) requiring repeated drainage and considered by the investigator to be unsuitable for enrollment;\n8. Prior allogeneic stem cell or solid organ transplantation;\n9. Prior exposure to any of the following: (1) combination or sequential therapy targeting DLL3, CD3, or CD28; (2) treatment with antibody-drug conjugates (ADCs); (3) major surgery, chemotherapy, biologic therapy, endocrine therapy, or macromolecular targeted therapy within 4 weeks prior to the first administration. Traditional Chinese medicine and small molecule targeted therapy with anti-tumor indications ≤ 2 weeks from the first administration of the investigational product;\n10. Known history of severe allergic reactions, anaphylactoid reactions, or other hypersensitivity reactions to humanized antibodies or fusion proteins, severe allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies, or allergy to components of the investigational product preparations;\n11. Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first administration of the investigational product;\n12. Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg after active treatment);\n13. Active central nervous system (CNS) metastases and\u002For carcinomatous meningitis known or diagnosed at screening. However, the following participants are allowed to be enrolled: 1) Patients with asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain metastases, no requirement for corticosteroids, and lesion size ≤ 1.5 cm) may be included, but are required to receive regular brain imaging as a site of disease. 2) Participants with treated brain metastases that have been stable for at least 2 months (confirmed by 2 imaging assessments at least 4 weeks apart following brain metastasis treatment), with no evidence of new or enlarging brain metastases and discontinued steroids at least 3 days prior to administration (stable brain metastases here should be confirmed before the first administration of the investigational product).\n14. Patients with known active or suspected autoimmune diseases. Patients with autoimmune-related hypothyroidism who are receiving thyroid hormone replacement therapy and those with type 1 diabetes mellitus controlled with insulin therapy are eligible to be enrolled;\n15. Patients who have received systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent dose of a similar drug) or other immunosuppressive agents within 14 days prior to the first administration; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; those with short-term use of corticosteroids for prophylaxis if a contrast agent is used;\n16. Patients with active tuberculosis;\n17. Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or a history of organ transplantation;\n18. Patients with active HBV or HCV infection or HBV\u002FHCV co-infection; Note: Patients who are HBsAg (+) and\u002For HBcAb (+) must undergo an HBV-DNA test and have a result \\\u003C 500 IU\u002FmL, \\\u003C 2500 copies\u002FmL, or \\\u003C ULN to be enrolled. Enrolled participants with detectable HBV-DNA must consent to receive antiviral nucleoside\u002Fnucleotide therapy.\n\n    If HCV antibody (+), HCV-RNA must be tested, and the result must be \\\u003C ULN for the participant to be eligible.\n\n    Participants with HBV\u002FHCV co-infection shall be excluded (positive for HBsAg or HBcAb and positive for HCV antibody).\n19. Have received live vaccines within 28 days prior to the first administration;\n20. Pregnant or lactating women;\n21. Participants who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.",{"count":200,"type":22},138,[25],"This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.",[204,205],"SCLC","NEC","2026-04-23",{"date":208,"type":33},"2026-04-29",{"date":210,"type":33},"2026-04-17",{"date":212,"type":22},"2029-06-30",{"name":38,"class":39},2,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":233,"leadSponsor":235,"locationsCount":4},"100634729","phase-1-a-phase-i-multicentre-randomized-double-blind-parallel-controlled-study-of-hlx05-n-vs-erbitux-in-metastatic-colorectal-cancer-100634729","NCT07543471","A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer","A Multicentre, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic, Efficacy, Safety, and Immunogenicity Profiles of HLX05-N vs. ERBITUX® (US\u002FEU-sourced) in Participants With Metastatic Colorectal Cancer","PK similarity","Inclusion Criteria:\n\n* 1\\. Participants must have signed and dated an IRB\u002FIEC approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines, and is willing to comply with all study procedures and rules required by the protocol.\n\n  2\\. Male or female aged 18-75 years (inclusive) when signing the ICF. 3. 18.5 kg\u002Fm2 ≤ Body mass index (BMI) ≤ 30 kg\u002Fm2 and 50kg ≤ Body weight ≤ 85kg. 4. Participants with a KRAS and NRAS wild type and with no BRAF V600E mutation mCRC.\n\n  5\\. Participants have histologically or cytologically documented locally advanced (unresectable) or metastatic colorectal adenocarcinoma originating from the splenic flexure to the rectum (left colon and rectum).\n\n  6\\. Has not previously received first-line systemic anti-tumor therapy (including systemic chemotherapy, molecular targeted therapy, biological therapy, and other investigational drugs) for recurrent or metastatic CRC\n\nExclusion Criteria:\n\n* 1\\. History of illicit drug use or alcohol abuse in the investigator's judgment within 12 months prior to screening.\n\n  2\\. Prior treatment with VEGF pathway-targeted therapy, EGFR pathway-targeted therapy, or signal transduction inhibitors (e.g., tyrosine kinase inhibitors).\n\n  3\\. Received radiotherapy within 6 months prior to randomization, with the exception of palliative radiotherapy for bone lesions completed more than 14 days prior to randomization. Radiotherapy covering more than 30% of the bone marrow area within 28 days prior to randomization is not permitted.\n\n  4\\. Underwent any major surgery within 4 weeks prior to randomization, or has not fully recovered from any surgery (placement of a vascular access device is not considered a major or minor surgery). For this study, a major surgery is defined as a procedure requiring at least a 3-week recovery period before the participant can receive treatment under this protocol.\n\n  5\\. Has had other active malignancies within 5 years prior to randomization. Participants with cured localized tumors, such as basal cell carcinoma in situ of the skin, squamous cell carcinoma in situ of the skin, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast carcinoma in situ, or thyroid carcinoma in situ, may be enrolled.",{"count":224,"type":22},387,[25],"This is a multicentre, randomized, double-blind, parallel-controlled Phase 1 clinical study designed to evaluate the pharmacokinetic (PK) similarity, efficacy, safety, and immunogenicity of HLX05-N compared with US-sourced ERBITUX® and EU-sourced ERBITUX® in participants with metastatic colorectal cancer (mCRC) with wild-type KRAS\u002FNRAS and no BRAF V600E mutation.\n\nApproximately 387 participants will be randomized in a 1:1:1 ratio to receive HLX05-N, US-ERBITUX®, or EU-ERBITUX®. Randomization will be stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) and sex (male vs. female).\n\nDuring the treatment period, participants will receive study treatment in combination with mFOLFOX6 chemotherapy. For the first 3 treatment cycles, participants will receive HLX05-N or US-\u002FEU-ERBITUX® plus chemotherapy according to randomized assignment. After completion of the initial 3 cycles, participants originally assigned to the US-ERBITUX® or EU-ERBITUX® arms will switch, in a blinded manner, to HLX05-N 250 mg\u002Fm² administered in combination with chemotherapy on Day 1 of each cycle. Study treatment will continue until investigator-assessed disease progression, death, initiation of new anti-tumor therapy, unacceptable toxicity, withdrawal of informed consent, study termination, or 1 year after randomization, whichever occurs first.\n\nFor participants with disease response or stable disease after 12 cycles of treatment, oxaliplatin may be discontinued, and maintenance therapy with cetuximab in combination with leucovorin and 5-fluorouracil may continue. Participants who continue to benefit from treatment after 1 year following randomization may receive subsequent therapy according to local clinical practice.\n\nPK and anti-drug antibody (ADA) samples will be collected from all participants to assess PK characteristics and immunogenicity. An end-of-treatment visit will be performed within 7 days after treatment discontinuation. Safety follow-up will be conducted 30 days after the last dose, with an additional telephone safety follow-up at 12 weeks after the last dose. Survival follow-up will continue for up to 1 year after randomization.",[228],"mCRC","2026-04-21",{"date":231,"type":33},"2026-04-24",{"date":30,"type":22},{"date":234,"type":22},"2028-04-30",{"name":38,"class":39},{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":243,"minAge":18,"maxAge":19,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":256,"locationsCount":63},"100575197","phase-2-a-phase-ii-clinical-study-to-evaluate-the-efficacy-and-safety-of-hlx43-anti-pd-l1-adc-in-patients-with-advanced-gynecological-malignant-tumors-100575197","NCT06769152","A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors","A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent\u002FMetastatic Gynecological Malignant Tumors Failed or Intolerance to Standard First-Line Therapy","Inclusion Criteria:\n\n1. Volunteer to participate in clinical research; To fully understand and understand this study and to sign the Informed Consent Form (ICF); Willing to follow and able to complete all test procedures;\n2. The age of signing ICF is ≥ 18 years old and ≤ 75 years old;\n3. Cohort 1: Metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology confirmed by histopathology or cytology.\n\n   Cohort 2: Histologically confirmed high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.\n4. Cohort 1: Previous failure or progression of standard systemic therapy for cervical cancer (For patients with PD-L1 expression positive \\[CPS≥1\\], the standard therapy is defined as platinum-based chemotherapy in combination with immune checkpoint inhibitor (ICI) therapy; for patients with PD-L1 expression negative \\[CPS\\\u003C1\\], the standard therapy is defined as platinum-based chemotherapy), or intolerability toxicity (CTCAE≥3 adverse events), or contraindications to standard therapy.\n\n   Cohort 2: Ovarian cancer patients with platinum-resistant disease: If the patient has previously received only first-line platinum-based chemotherapy, platinum resistance is defined as having received at least 4 cycles of platinum-based chemotherapy, with the tumor showing a response to platinum-based chemotherapy (best tumor assessment being complete remission\u002Fpartial remission), and the time from the last platinum-based chemotherapy to tumor progression being \\>3 months and ≤6 months. If the patient has previously received multiple lines of platinum-based chemotherapy, platinum resistance is defined as disease progression occurring during the last line of platinum-based chemotherapy treatment or within 6 months after the last platinum-based chemotherapy.\n5. Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST v1.1 criteria;\n6. Tumor tissue should be provided as much as possible for an evaluable PD-L1 expression result at Screening period；\n7. Before the initial administration of the study drug, there should be at least a 3-week interval or 5 times the half-life of the last cytotoxic chemotherapy, immunotherapy, or biological therapy, whichever is shorter. There should be at least a 2-week interval from the previous small molecule targeted therapy, at least a 1-week interval from traditional Chinese medicine treatment with antitumor indications or minor surgery. Additionally, treatment-related adverse events (AEs) should have recovered to NCI-CTCAE grade ≤ 1 (except for grade 2 peripheral neurotoxicity and alopecia)；\n8. The ECOG physical performance score of 0-1 in the week prior to randomization；\n9. Expected survival ≥ 3 months；\n10. Laboratory tests within the previous week confirm adequate organ function (within 14 days prior to the first dose of medication, without receiving interventions such as blood transfusions or granulocyte colony-stimulating factor)；\n11. Female subjects of childbearing potential must agree to use at least one highly effective method of contraception during the trial and for at least 6 months after the last dose of the study drug. Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n1. History of any second malignant tumor within the first 2 years prior to randomization;\n2. Subjects who are preparing for or have previously received an organ or bone marrow transplant;\n3. Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases;\n4. After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently;\n5. Present with grade ≥1 radiation pneumonia as defined by RTOG\u002FEORTC; A history of interstitial lung disease (ILD) or imaging findings during screening that suggest such disease is suspected; Or there are lung diseases leading to clinical severe respiratory impairment;\n6. Subjects exhibit poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure, or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) unstable angina; (3) myocardial infarction or cerebrovascular accident within the last 6 months (excluding lacunar infarction, minor ischemic stroke, or transient ischemic attack); (4) uncontrolled arrhythmias (including QTc interval ≥ 450 ms for males, ≥ 470 ms for females) (QTc interval calculated by Fridericia's formula); (5) poorly controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg despite active treatment);\n7. Previous occurrence of adverse events leading to permanent discontinuation of immunotherapy; or A history of ≥ Grade 2 immune-related pneumonia or myocarditis;\n8. Active or suspected autoimmune disease. Patients with autoimmune-related hypothyroidism who are undergoing thyroid hormone replacement therapy are permitted to participate in the study; patients with controlled Type 1 diabetes mellitus receiving insulin therapy are also allowed to participate in the study;\n9. Received systemic corticosteroids (prednisone \\>10 mg\u002Fday or an equivalent dose of similar drugs) or other immunosuppressive treatments within 14 days prior to the first dose; with the following exceptions: use of topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylactic treatment during situations such as the use of contrast agents;\n10. Within the 2 weeks prior to randomization, there is the presence of an active systemic infectious disease requiring intravenous antibiotic treatment;\n11. Live vaccinations or attenuated live vaccinations should not be administered within 4 weeks prior to the initial dosing. Administration of inactivated viral vaccines for seasonal influenza is permitted;\n12. Used strong inhibitors or strong inducers of CYP2D6 or CYP3A within 2 weeks prior to randomization;\n13. Known history of severe allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies, or allergy to components of the trial drug formulation; Previously received ADC drugs with topoisomerase I inhibitors as toxins.\n14. Active tuberculosis;\n15. Human immunodeficiency virus (HIV) infection;\n16. Active Hepatitis B or Hepatitis C virus (HBV or HCV) infection or HBV\u002FHCV co-infection;\n17. Pregnant or lactating women;\n18. The researcher deems that the subject has any other factors that make them unsuitable for participation in this trial.","FEMALE",{"count":245,"type":22},190,[51],"The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent\u002Fmetastatic cervical cancer or ovarian cancer failed or intolerance to standard first-line therapy.",[249,250],"Cervical Cancer","Ovarian Cancer",{"date":252,"type":33},"2026-04-22",{"date":254,"type":33},"2025-02-20",{"date":190,"type":22},{"name":38,"class":39},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":275,"leadSponsor":277,"locationsCount":4},"100632773","phase-1-a-study-of-hlx18-vs-opdivo-in-multiple-resected-solid-tumors-100632773","NCT07518043","A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors","A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX18 vs. OPDIVO® (US-sourced OPDIVO®) in Multiple Resected Solid Tumors","Inclusion Criteria:\n\n1. Participants must have signed and dated an IRB\u002FIEC approved written informed consent form.\n2. Aged 18 to 70 years at the time of signing the ICF.\n3. 18 kg\u002Fm² ≤ BMI ≤ 30 kg\u002Fm² and 50 kg ≤ body weight ≤ 85 kg.\n4. Histologically confirmed solid tumors (EC\u002FGEJC, Melanoma, or UC) status post R0 resection.\n5. For EC\u002FGEJC: residual pathologic disease (non-pCR) following neoadjuvant chemoradiotherapy and R0 resection.\n6. For Melanoma: Stage IIB-IV after complete surgical resection with documented negative margins.\n7. For UC: High-risk muscle-invasive urothelial carcinoma (MIUC) following radical resection (R0).\n8. Documented disease-free status (no recurrence) by imaging and physical exam within 4 weeks prior to randomization.\n9. Adequate recovery from prior surgery or systemic therapy.\n10. ECOG Performance Status of 0.\n11. Adequate organ function.\n12. Agreement to use effective contraception (negative pregnancy test for WOCBP).\n\nExclusion Criteria:\n\n1. History of illicit drug use or alcohol abuse within 12 months prior to randomization.\n2. Tumor-specific exclusions: cervical esophageal cancer, Stage IV EC\u002FGEJC, or ocular melanoma.\n3. UC-specific surgical exclusions: status post partial cystectomy or partial nephrectomy.\n4. EC\u002FGEJC treatment violations: failure to receive mandatory preoperative concurrent CRT (mono-therapy is ineligible).\n5. Prior treatment with nivolumab or any other immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4).\n6. Other primary active malignancies within 5 years or history of organ\u002Fbone marrow transplantation.\n7. Significant cardiovascular disease (MI, cerebrovascular disease) or unstable arrhythmia (QTc \\> 450ms\u002F470ms) within 6 months.\n8. Chronic heart failure (NYHA Class III-IV) or LVEF \\\u003C 50% at screening.\n9. Presence of interstitial pneumonia, pneumonitis, or severe lung function abnormalities.\n10. Active autoimmune disease requiring systemic immunosuppressive therapy.\n11. Known HIV infection, active Hepatitis B\u002FC, or active pulmonary tuberculosis.\n12. Peripheral neuropathy ≥ Grade 2 or history of carcinomatosis meningitis.\n13. Use of systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent), immunosuppressants, or live vaccines within 28 days.\n14. Recent or planned participation in other investigational drug, device, or surgical studies.\n15. Severe allergic reactions to monoclonal antibodies or any condition deemed unsuitable by the investigator.\n16. The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.","70 Years",{"count":157,"type":22},[25],"This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX18 and OPDIVO® in patients with resected esophageal or gastroesophageal junction cancer (EC\u002FGEJC), melanoma (MEL), or urothelial carcinoma (UC).",[269,162,270],"Esophageal and\u002For Cardia Cancer","Urothelial Carcinoma (UC)","2026-04-12",{"date":273,"type":33},"2026-04-15",{"date":30,"type":22},{"date":276,"type":22},"2028-06-13",{"name":38,"class":39},{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":295,"leadSponsor":297,"locationsCount":4},"100633978","phase-1-a-phase-i-clinical-study-of-hlx3902-in-patients-with-mcrpc-and-other-advanced-tumours-100633978","NCT07533708","A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours","A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX3902 (a STEAP1xCD3xCD28 Trispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Advanced Solid Tumours","Inclusion Criteria\n\n1. Voluntarily signed written informed consent and willing to comply with study procedures.\n2. Age: ≥ 18 years, regardless of gender.\n3. Histologically confirmed advanced or metastatic solid tumours (e.g., metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer, or gastric cancer) following failure of standard therapy.\n4. mCRPC specifics: 1）Progression or refractory status after ≥ 1 novel anti-androgen agent and failure of 1-2 taxane-based regimens.\n\n2）Ongoing surgical or medical castration (gonadotropin-releasing hormone agonist or antagonist) with serum testosterone ≤ 50 ng\u002FdL.\n\n3）Documented disease progression (prostate-specific antigen, nodal, visceral, or bone) .\n\n5\\. Presence of at least one measurable lesion per RECIST criteria version 1.1. 6. ECOG Performance Status of 0-1. 7. Expected survival exceeding 3 months. 8. Agreement to provide archived or fresh tumour tissue. 9. Adequate organ function. 10. Agreement to use effective contraception for both genders and negative pregnancy test for females of childbearing potential.\n\nExclusion Criteria\n\n1. Presence of histological types other than adenocarcinoma in mCRPC; or neuroendocrine or small cell differentiation in other solid tumours.\n2. Active or symptomatic central nervous system metastases, carcinomatous meningitis, or spinal cord compression (stable treated brain metastases meeting protocol criteria are allowed).\n3. Active malignancies within two years prior to the first dose, except cured carcinoma in situ or basal cell carcinoma of the skin.\n4. Prior STEAP1-targeted therapy, or Radium-223\u002FPSMA radionuclide therapy within 6 months.\n5. Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, or endocrine therapy (excluding LHRH\u002FGnRH analogues) within 28 days; small molecule drugs within 14 days.\n6. Vaccination with live vaccines within 28 days.\n7. Systemic corticosteroids (\\> 10 mg\u002Fday Prednisone equivalent) or other immunosuppressants within 14 days.\n8. Currently participating in another interventional study or within 4 weeks of the end of treatment in such a study.\n9. Adverse events from prior therapy not resolved to Grade ≤ 1, except for alopecia, ear toxicity, or stable Grade ≤ 2 taxane-related neurotoxicity.\n10. History of Grade ≥ 2 immune-related pneumonitis or myocarditis, or severe\u002Flife-threatening immune-mediated adverse events during prior immunotherapy.\n11. Poorly controlled cardiovascular disease within 6 months, unstable angina, stroke, thromboembolic events, or uncontrolled hypertension or arrhythmia.\n12. Evidence of interstitial lung disease, or active non-infectious pneumonitis.\n13. Active or suspected autoimmune disease, hypophysitis, or unstable pituitary dysfunction requiring systemic therapy.\n14. Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks, active tuberculosis, or positive for HIV, active HBV (HBV DNA ≥ 500 IU\u002FmL), or HCV.\n15. History of organ transplantation, central nervous system diseases within 12 months (e.g., seizures, dementia), or any condition that makes the participant unsuitable per Investigator.",{"count":286,"type":22},48,[25],"This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3902 in patients with mCRPC and other advanced solid tumours.",[290],"mCRPC or Advanced\u002FMetastatic Solid Tumors","2026-04-09",{"date":293,"type":33},"2026-04-16",{"date":98,"type":22},{"date":296,"type":22},"2028-05-24",{"name":38,"class":39},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":305,"sex":306,"minAge":18,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":63},"100631073","phase-1-pharmacokinetic-characteristics-safety-and-immunogenicity-of-hlx319-compared-with-eu-phesgo-100631073","NCT07495930","Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®","A Randomized, Double-blind, Single Subcutaneous Administration, Parallel Control Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo® in Chinese Healthy Male Subjects.","Inclusion Criteria:\n\n1. Male subjects aged ≥18 and ≤45 years;\n2. The skin at the injection site is intact, without damage, tattoos, or other markings;\n3. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;\n4. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.\n5. Body weight (BW) ≥50 and ≤75 kg;\n6. Body mass index (BMI) ≥19 and ≤24 kg\u002Fm² \\[BMI = weight (kg) \u002F height² (m²)\\];\n7. Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%);\n\nExclusion Criteria:\n\n1. Clinically significant diseases including but not limited to the gastrointestinal tract, kidneys, liver, nerves, blood, endocrine system, tumors, respiratory system, immune system, mental health, and cardiovascular and cerebrovascular diseases;\n2. History of allergy or hypersensitivity reactions.\n3. Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;\n4. History of blood donation or blood loss (\\>450mL) within 3 months prior to randomization;\n5. Positive test results for Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV) antibodies, and Human Immunodeficiency Virus (HIV) antibodies, or abnormal and clinically significant quantitative test results for syphilis spirochetes as determined by the sub investigator;\n6. History of upper respiratory tract infection or other acute infections within 2 weeks prior to r randomization;\n7. History of drug abuse, substance use;\n8. History of alcoholism or positive alcohol test results;\n\n11\\. History of long-term heavy smoking .",true,"MALE","45 Years",{"count":309,"type":22},24,[25],"The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent clinical study protocols.",[313],"Health Adult Subjects","2026-03-26",{"date":316,"type":33},"2026-04-01",{"date":318,"type":22},"2026-04-30",{"date":320,"type":22},"2026-10-10",{"name":38,"class":39},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":63},"100630426","phase-2-phase-ii-study-of-hlx43-monotherapy-or-combined-with-immune-checkpoint-inhibitors-in-patients-with-locally-advanced-recurrent-or-metastatic-triple-negative-breast-cancer-100630426","NCT07487519","Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.","A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) as a Monotherapy or in Combination With Immune Checkpoint Inhibitors in Subjects With Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (TNBC).","Inclusion Criteria:\n\n1. Voluntary written informed consent obtained before any study procedures.\n2. Age ≥ 18 years at consent; no gender restriction.\n3. Histopathologically confirmed TNBC: ER \\\u003C 1%, PR \\\u003C 1%, HER2 IHC 0\u002F1+\u002F2+ with no FISH amplification.\n\n   * Phase I: Recurrent or metastatic TNBC after ≥1 prior line of standard systemic therapy.\n   * Phase II: Unresectable locally advanced, recurrent, or metastatic TNBC with no prior systemic anti-cancer therapy for this stage (palliative radiotherapy to metastases allowed; neoadjuvant\u002Fadjuvant therapy permitted if completed ≥6 months before recurrence\u002Fmetastasis).\n4. At least one RECIST v1.1-measurable lesion documented within 4 weeks before randomization.\n\n   Note: Target lesions must not be in irradiated fields or the CNS. If only measurable lesion is irradiated, imaging must confirm progression post-radiotherapy.\n5. Archival FFPE tumor tissue (≤6 months old, ≤2 years max) for PD-L1 testing; fresh biopsy acceptable if archival tissue is unavailable or inadequate.\n\n   Note: Specimens must be non-irradiated FFPE blocks\u002Fslides with pathology report confirming malignancy and adequacy.\n6. Washout: ≥3 weeks (or 5 half-lives, whichever is shorter) after major surgery, radiotherapy (except palliative bone RT), chemotherapy, targeted therapy, or immunotherapy; ≥1 week after minor surgery or anti-tumor TCM. All treatment-related AEs resolved to CTCAE v6.0 Grade ≤1 (stable Grade 2 peripheral neuropathy and alopecia exempted).\n7. ECOG PS 0-1, assessed ≤7 days before randomization.\n8. Life expectancy \\>3 months.\n9. Adequate hematologic, hepatic, and renal function per labs ≤7 days before randomization.\n\nExclusion Criteria:\n\n1. Prior topoisomerase I-targeting therapy (e.g., irinotecan, topotecan, or ADCs).\n2. Second primary malignancy within 2 years before randomization (except cured carcinoma in situ or stage I tumors).\n3. Prior grade ≥3 immune-related adverse event during immunotherapy.\n4. Uncontrolled, recurrent malignant pleural, pericardial, or ascitic effusions requiring repeated drainage.\n5. Active CNS metastases, spinal cord compression, or carcinomatous meningitis.\n6. Clinically significant pulmonary impairment.\n7. Uncontrolled cardiovascular or cerebrovascular disease .\n8. Active systemic infection requiring IV antibiotics within 2 weeks before randomization.\n9. Moderate or strong CYP2D6\u002FCYP3A inhibitor or inducer use within 2 weeks before randomization.\n10. Systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressants within 2 weeks before randomization .\n11. Active or suspected autoimmune disease .\n12. Live or attenuated live vaccine within 4 weeks before randomization.\n13. Hypersensitivity to mAbs, large-molecule biologics, or drug formulation excipients.\n14. Active pulmonary tuberculosis.\n15. Known immunodeficiency.\n16. Active HBV , HCV , or HBV\u002FHCV co-infection.\n17. Pregnancy or lactation.\n18. Participation in another interventional trial within 30 days before consent .\n19. Any condition posing unacceptable safety risk or interfering with study conduct per investigator judgment.",{"count":330,"type":22},180,[51],"The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) as a monotherapy or in combination with immune checkpoint inhibitors in Subjects with locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC).",[334],"Breast Cancer (Triple Negative Breast Cancer (TNBC))","2026-03-17",{"date":337,"type":33},"2026-03-23",{"date":339,"type":22},"2026-04-25",{"date":341,"type":22},"2028-05-22",{"name":38,"class":39},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":63},"100615584","phase-2-a-study-to-evaluate-hlx22-in-combination-with-hlx87-in-patients-with-her2-positive-recurrent-or-metastatic-breast-cancer-100615584","NCT07294508","A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer","An Open-Label, Randomized, Multicenter, Phase II\u002FIII Clinical Study to Evaluate HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With HLX87 (HER2 ADC) as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer","Inclusion Criteria:\n\n* 1\\. Have a full understanding of the study content, and sign the informed consent form (ICF); 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Histopathologically confirmed breast cancer that meets the following criteria:\n\n  1. Advanced or metastatic breast cancer.\n  2. HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+.\n  3. Positive or negative for hormone receptor HR (including estrogen receptor \\[ER\\] and progesterone receptor \\[PgR\\]) as determined by the central laboratory 4. No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer (1 line of endocrine therapy is allowed).\n\n  5\\. At least one measurable lesion as assessed by central imaging according to RECIST v1.1.\n\n  7\\. Eastern Cooperative Oncology Group performance status score within 7 days prior to the first dose of study drugs: 0-1.\n\n  8\\. Life expectancy ≥ 12 weeks. 9. Adequate organ functions\n\nExclusion Criteria:\n\n* 1\\. History of a second malignancy within 3 years prior to signing the ICF. 2. Previous use of doxorubicin with a concentration of \\> 360 mg\u002Fm2 (or equivalent).\n\n  3\\. Prior treatment with ADCs including exatecan derivatives that contain topoisomerase I inhibitors.\n\n  4\\. Uncontrolled or significant cardiovascular diseases 5. Cerebrovascular accidents within 6 months prior to the first dose of study drugs.\n\n  6\\. ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis or clinically significant lung-specific intercurrent illness .\n\n  7\\. Active infection . 8. Presence of spinal cord compression or clinically symptomatic central nervous system metastases.\n\n  9\\. Residual toxicity from previous anti-tumor therapy that has not resolved to Grade ≤ 1 as per NCI-CTCAE V6.0 or baseline level (except for alopecia).\n\n  10\\. Presence of active tuberculosis. 11. Have received treatment with live attenuated vaccines within 30 days prior to the first dose of study drugs.\n\n  12\\. Known history of severe allergic reaction to macromolecular protein preparations, hypersensitivity to the ingredient of the investigational products, or severe hypersensitivity to any excipient of the study drugs.\n\n  13\\. Known history of abuse of psychotropic drugs or drug addiction. 14. Pregnant or lactating women.",{"count":72,"type":22},[51,74],"The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer",[139],{"date":355,"type":33},"2026-03-20",{"date":357,"type":33},"2026-02-27",{"date":359,"type":22},"2030-12-30",{"name":38,"class":39},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":305,"sex":306,"minAge":18,"maxAge":307,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":369,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":376,"leadSponsor":378,"locationsCount":63},"100630224","phase-1-a-study-to-evaluate-the-safety-pk-and-immunogenicity-of-recombinant-human-hyaluronidase-in-healthy-subjects-100630224","NCT07484893","A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects","A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Chinese Adult Male Subjects","Inclusion Criteria:\n\n* Healthy male subjects, aged ≥ 18 and ≤ 45 years.\n* Body Mass Index (BMI) ≥ 18.0 and ≤ 28.0 kg\u002Fm².\n* Intact skin at the injection site, with no damage, tattoos, or other markings.\n* No significant medical history, or a history of abnormalities that, in the investigator's judgment, will not impact the study.\n* Physical examination, vital signs, electrocardiogram (ECG), chest X-ray, and clinical laboratory tests are normal or abnormal without clinical significance (NCS).\n* Subjects must agree to use highly effective contraception with their spouse or partner from the time of signing the Informed Consent Form (ICF) until 3 months after the last dose, or the subject is not capable of reproduction. Subjects must also refrain from sperm donation during the study and for 3 months following the last dose of the investigational product.\n* Voluntarily signed the Informed Consent Form (ICF) prior to any study procedures, with a full understanding of the study content, procedures, and potential adverse events (AEs); and the ability to comply with the protocol requirements to complete the study.\n\nExclusion Criteria:\n\n* History of drug abuse or or substance use, or a positive drug screen; history of long-term heavy alcohol consumption (defined as consuming more than 14 units of alcohol per week within 3 months prior to screening \\[1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine\\]) or a positive blood alcohol test; history of long-term heavy alcohol use or positive blood alcohol test; history of long-term heavy smoking (defined as an average of more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from smoking during the ).\n* Cardiac disorders, including but not limited to clinically significant ECG abnormalities during the screening period, QTcF \\> 450ms, or a history of clinically significant ECG abnormalities.\n* History of any clinically severe hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or oncological diseases, or allergic diseases.\n* History of upper respiratory tract infection or other acute infections within 7 days prior to the first dose, or systemic use of antibiotics within 7 days.\n* Known allergy to recombinant human hyaluronidase for injection or its formulation components; history of severe allergic reactions to any medication (e.g., angioedema); special dietary requirements or inability to comply with the standardized diet provided by the clinical site.\n* Use of any prescription drugs, over-the-counter (OTC) medications, or herbal medicines within 4 weeks prior to screening (especially salicylates, cortisone, adrenocorticotropic hormone, estrogens, or antihistamines, except for routine vitamin supplements), or within 5 half-lives of the medication (whichever is longer).\n* Vaccination within 1 month prior to administration.\n* History of blood donation or blood loss ≥ 400 mL within 3 months prior to the use of the investigational product.\n* Participation in any other clinical study and use of investigational\u002Fcontrol products within 3 months prior to the investigational product administration.\n* Positive for HBsAg, anti-HCV, anti-HIV, or the syphilis spirochete test.\n* Sensory-motor disorders or autonomic movement disorders.\n* Any condition which, in the investigator's judgment, would make the subject unable to comply with the protocol requirements, instructions, or study restrictions, such as an uncooperative attitude, inability to return for follow-up visits, or inability to complete the study.",{"count":309,"type":22},[25],"The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.",[372],"Healthy Adult Male","2026-03-16",{"date":355,"type":33},{"date":164,"type":22},{"date":377,"type":22},"2026-10-24",{"name":38,"class":39},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":23,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":4},"100629900","phase-1-phase-i-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-hlx97-a-kat6ab-inhibitor-in-patients-with-advancedmetastatic-solid-tumor-100629900","NCT07480681","Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A\u002FB Inhibitor) in Patients With Advanced\u002FMetastatic Solid Tumor","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (KAT6A\u002FB Small Molecule Inhibitor) in Patients With Advanced\u002FMetastatic Solid Tumor","Inclusion Criteria:\n\n* Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;\n* 18-80 years of age, either sex;\n* Subjects who meet the corresponding requirements below will be enrolled.\n\n  1. Part 1A will enroll subjects with histologically or cytologically confirmed advanced\u002Fmetastatic HR-positive, HER2-negative breast cancer (BC), castration-resistant prostate cancer (CRPC), or non-small cell lung cancer (NSCLC) who have failed standard therapy or for whom no standard therapy exists.\n  2. Part 1B will enroll subjects with histologically or cytologically confirmed advanced or metastatic HR-positive, HER2-negative breast cancer.\n  3. Part 2 will enroll subjects with histologically or cytologically confirmed advanced or metastatic HR-positive, HER2-negative breast cancer.\n* ECOG performance status of 0-1;\n* Life expectancy ≥ 12 weeks;\n* Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n* History of any second malignancy within 3 years prior to signing the ICF. Exceptions include early-stage malignancies (carcinoma in situ or Stage I tumors) that have been curatively treated, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, or papillary thyroid cancer.\n\nActive systemic infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose.\n\nSubjects with poorly controlled clinical symptoms or diseases of the cardiovascular and cerebrovascular system, including but not limited to:\n\nNYHA Class ≥II heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50%; Unstable angina; Myocardial infarction or cerebrovascular accident within 6 months (excluding lacunar infarction, minor cerebral ischemia, or transient ischemic attack); Poorly controlled arrhythmias (including QTc interval ≥450 ms for males or ≥470 ms for females, calculated using the Fridericia formula); Poorly controlled hypertension (systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite active treatment).\n\nPresence of spinal cord compression or clinically symptomatic central nervous system (CNS) metastases, defined as untreated, symptomatic, or requiring corticosteroids or anticonvulsants to control symptoms. Subjects with stable brain metastases may be included. Subjects with previously diagnosed brain metastases are eligible if they have completed treatment, have recovered from the acute effects of radiotherapy or surgery prior to enrollment, have discontinued corticosteroid therapy for these metastases for at least 3 weeks, and are neurologically stable for 2 months (requiring MRI confirmation).\n\nPresence of residual toxicity from prior anti-tumor therapy that has not resolved, defined as toxicity not resolved to Grade ≤1 or baseline levels per CTCAE V5.0 (alopecia excepted).\n\nNote: Subjects with chronic, stable Grade 2 toxicity deemed by the investigator to be related to prior anti-tumor therapy (defined as no worsening to ≥ Grade 2 for at least 3 months prior to enrollment and managed with standard medical measures) may be enrolled; for example: chemotherapy-induced neuropathy, fatigue, and residual toxicity from prior immunotherapy (Grade 1 or 2 endocrinopathies, which may include hypothyroidism\u002Fhyperthyroidism, Type 1 diabetes mellitus, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation\u002Fvitiligo).\n\nPrior radiotherapy to bone marrow involving \\>25% of the total bone marrow volume (e.g., prior whole pelvic radiotherapy, whole spine radiotherapy, etc.; excluding local radiotherapy to single or a few vertebral bodies, local radiotherapy to the chest wall, etc.).\n\nUncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (defined as requiring drainage at least once monthly).\n\nUse of therapeutic anticoagulants. Low molecular weight heparin is permitted. Use of vitamin K antagonists or Factor Xa inhibitors may be permitted after discussion with the sponsor.\n\nActive inflammatory gastrointestinal disease, refractory or unresolved chronic diarrhea, or history of gastrectomy, gastric banding surgery, or other gastrointestinal conditions or surgeries that could significantly alter the absorption of HLX97 tablets. Treated gastroesophageal reflux disease is permitted.\n\nPatients who received systemic corticosteroids (prednisone ≥10 mg\u002Fday or equivalent dose of similar medication) or other immunosuppressive agents within 14 days prior to the first dose.\n\netc","80 Years",{"count":200,"type":22},[25],"This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary efficacy of HLX97 ( KAT6A\u002FB inhibitor) in patients with advanced\u002Fmetastatic solid tumors.",[28],"2026-03-13",{"date":393,"type":33},"2026-03-18",{"date":395,"type":22},"2026-03",{"date":397,"type":22},"2028-06",{"name":38,"class":39},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":406,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":420},"100606522","phase-1-phase-i-clinical-study-to-evaluate-pharmacokinetic-profile-safety-efficacy-and-immunogenicity-of-ipilimumab-biosimilar-hlx13-vs-yervoy-us-sourced-yervoy-as-a-first-line-treatment-for-patients-with-unresectable-hepatocellular-carcinoma-100606522","NCT07176650","Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma","A Randomized, Multicenter, Double-Blind, Parallel-Controlled, Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Subjects must have signed and dated an IRB\u002FIEC-approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines.\n2. Male or female, 18 years ≤ age ≤ 65 years at the time of signing the ICF.\n3. Body weight: 50 kg-85 kg.\n4. Histologically diagnosed hepatocellular carcinoma (HCC); and must have an advanced HCC, defined as: a) not eligible for curative surgical and\u002For locoregional therapies; or b) progressive disease after surgical and\u002For locoregional therapies. Subjects with only a radiologic diagnosis of hepatocellular carcinoma may be enrolled for screening in the study but histological confirmation is mandatory prior to randomization.\n5. At least one measurable lesion as assessed by investigator based on RECIST v1.1 within 4 weeks prior to the first dose in this study. The measurable lesion is not from sites that have been previously treated with surgery, radiotherapy, and\u002For locoregional therapy.\n6. No systemic therapy for relapsed metastatic or advanced hepatocellular carcinoma prior to screening. Note: prior neo-adjuvant or adjuvant systemic therapy is permitted if recurrence occurs ≥12 months after treatment completion.\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 within 7 days prior to the first dose.\n8. Cirrhotic status of Child-Pugh Class A within 7 days prior to the first dose.\n9. Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiography.\n10. Normal major organ functions prior to the first dose.\n11. For patients with active hepatitis B virus (HBV), the HBV-DNA must be less than 500 IU\u002FmL or 2500 copies\u002FmL within 28 days prior to the randomization, an anti-HBV treatment (e.g., entecavir) has been started prior to the randomization, and patients are willing to continue the treatment during this study. Patients with positive HCV-RNA must agree to receive standard anti-viral therapy per the local standard of care.\n12. Women of childbearing potential should have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the first dose.\n\nExclusion Criteria:\n\n1. With other histopathological types of hepatocellular carcinoma, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma.\n2. Other malignancies active within 3 years prior to or at screening except for localized tumors that have been cured such as basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n3. Liver transplant, or organ allograft or allogeneic bone marrow transplantation prior to screening, or the above transplantation is scheduled during the study.\n4. History of hepatic encephalopathy prior to screening.\n5. Clinically significant ascites.\n6. Patients with tumor thrombus at the main portal vein (Vp4), or inferior vena cava prior to screening, or clear invasion into the bile duct, or HCC with ≥50% liver occupation.\n7. Presence of nervous system disorders at screening.\n8. Evidence of portal hypertension with bleeding esophageal or gastric varices within 6 months prior to the randomization. The aforementioned patients have undergone endoscopy to exclude those with high hemorrhage risk may be enrolled. For a patient receiving endoscopy within 6 months prior to randomization, repeat examination is not required.\n9. Any other hemorrhage\u002Fbleeding event \\> CTCAE Grade 3 within 3 months prior to screening except for esophageal or gastric varices.\n10. History of non-healing wounds, bone fractures, or ulcers at risk of bleeding within 3 months prior to randomization.\n11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the randomization or those who receive minor surgical procedures (e.g., core biopsy) within 7 days prior to randomization.\n12. Known active or suspected autoimmune diseases prior to screening. Patients with stable disease who do not require systemic immunosuppressive therapy may also participate.\n13. Treatment with systemic corticosteroids (\\> equivalent dose of 10 mg\u002Fday prednisone) or other immunosuppressive agents within 14 days prior to the first dose or during the study. However, for patients with conditions other than active autoimmune diseases, inhaled or topical steroids or adrenocortical hormone replacement therapy (no more than the equivalent dose of 10 mg\u002Fday prednisone) are allowed.\n14. Active co-infection with both hepatitis B and C (or detectable HBV surface antigen or HBV-DNA and HCV-RNA at screening), or hepatitis D infection in subjects with hepatitis B.\n15. Subjects with a history of co-infection with both hepatitis B and C.\n16. Human immunodeficiency virus (HIV) infection prior to screening (or positive anti-HIV at screening).\n17. Any active infections (including, but not limited to bacteria, fungi, mycoplasma, chlamydia, and herpes zoster virus) requiring systemic treatment within 14 days prior to screening.\n18. Uncontrolled cardiovascular diseases within 6 months prior to screening.\n19. Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity prior to screening.\n20. Patients who have used traditional Chinese herbs or medicines with anti-tumor indications within 14 days prior to randomization.\n21. Patients who have received treatment with live vaccines within 28 days prior to randomization. Those who received inactivated viral vaccines for seasonal influenza or COVID-19 are eligible.\n22. Patients who have received any T-cell costimulatory agents or immune checkpoint blockade therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1\u002F2 inhibitors, or other agents that target T cells.\n23. Radical radiotherapy within 4 weeks prior to randomization.\n24. Other prior\u002Fconcomitant therapy: a) Treatment with strong CYP3A4 inducers within 1 week prior to randomization, including rifampin (and its analogues) or St. John's wort. b) Use of anticoagulants such as, warfarin or similar agents requiring therapeutic INR monitoring. Note: Treatment with low molecular weight heparin is allowed. c) Treatment with anti platelet therapy (aspirin at dose ≥ 300 mg\u002Fday, clopidogrel at dose ≥75 mg\u002Fday).\n25. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or IMP administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.\n26. Anaphylaxis to ipilimumab, nivolumab, or any other monoclonal antibody, or any component of the IMPs prior to screening.\n27. History of psychotropic substance abuse or illicit drug use as judged by the investigator prior to screening.\n28. Pregnant and lactating women, and those intending to become pregnant during the study or within 5 months after the last study treatment.\n29. Currently participating in another clinical study prior to screening, or less than 4 weeks or 5 half-lives of the IMPs in the previous study, whichever is longer, between the screening of the study and the end of treatment in the previous study.\n30. Patients who have other conditions not suitable for inclusion per investigator's judgments.","65 Years",{"count":408,"type":22},246,[25],"This is a multicenter, randomized, double-blind, parallel-controlled, phase I clinical study to evaluate the PK characteristics, safety, efficacy, and immunogenicity of HLX13 and US-sourced YERVOY® in patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.",[412],"Hepatocellular Carcinoma (HCC)","2026-03-12",{"date":373,"type":33},{"date":416,"type":33},"2025-11-25",{"date":418,"type":22},"2026-12",{"name":38,"class":39},51,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":441,"leadSponsor":443,"locationsCount":4},"100628292","phase-2-a-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-hlx43-in-patients-with-hormone-receptor-positive-her2-negative-locally-advanced-or-metastatic-breast-cancer-100628292","NCT07459738","A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer","A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Male\u002Ffemale who are at least 18 years of age and and no more than 75 years old on the day of signing the informed consent.\n2. With histologically confirmed diagnosis of HER2-negative, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.\n3. Must have experienced disease progression after receiving at least one line of endocrine therapy for advanced or metastatic disease.\n4. Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.\n5. ECOG PS: 0-1.\n6. Expected survival ≥ 6 months.\n7. Had adequate organ function\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors within 3 years before the randomization\n2. Prior documented interstitial lung disease (ILD)\u002F pneumonitis that required steroids, current ILD\u002F pneumonitis, or suspected ILD\u002Fpneumonitis\n3. Lung-specific intercurrent clinically significant illnesses\n4. Uncontrolled or significant cardiovascular disease or infection\n5. Prior adverse events leading to permanent discontinuation of immunotherapy; or prior immune-related pneumonia or immune-related myocarditis of grade ≥2.",{"count":49,"type":22},[51],"This is a Phase II Study of HLX43 in Hormone Receptor Positive，HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first)",[432],"Hormone Receptor Positive HER-2 Negative Breast Cancer",[434,435,436],"HLX43","anti-PD-L1 ADC","Breast Cancer","2026-03-05",{"date":439,"type":33},"2026-03-10",{"date":316,"type":22},{"date":442,"type":22},"2027-12-30",{"name":38,"class":39},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":451,"targetDuration":4,"studyType":23,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":214},"100581974","phase-2-a-phase-ii-clinical-study-to-evaluate-hlx43-in-subjects-with-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-100581974","NCT06857279","A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;\n2. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;\n3. Cohort 1： Patients with histologically confirmed recurrent\u002Fmetastatic head and neck squamous cell carcinoma who have been refractory to previous systemic treatment;\n\nCohort 2： Patients with histologically confirmed recurrent\u002Fmetastatic head and neck squamous cell carcinoma (HNSCC), including primary oropharyngeal, oral cavity, hypopharyngeal, or laryngeal carcinoma. Previous treatment must meet the following requirements:\n\n1. Have not received systemic anti-tumor therapy for HNSCC in the recurrent or metastatic setting.\n2. Have not experienced disease progression or recurrence within 6 months after completion of systemic anti-tumor therapy in the locally advanced setting.\n\n4\\. At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to randomization; 5. Subjects who agree to provide archived tumor tissue specimens that meets the testing requirements or agree to undergo a biopsy; 6. The following conditions must be met in terms of the time of the first administration of the investigational product: at least 3 weeks (or 5 half-lives of the drug, whichever is shorter) from the previous major surgery, medical device treatment, locoregional radiotherapy (except for palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biological product therapy; at least 2 weeks from the previous hormone therapy or small molecular targeted therapy; at least 1 week from the administration of the traditional Chinese medicine for anti-cancer indications or minor surgery; and recovery of treatment-induced AEs to Grade ≤ 1; 7. ECOG PS score of 0-1 within 1 week prior to randomization; 8. Life expectancy \\> 3 months; 9. Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization; 10. Male and female subjects with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female subjects of childbearing age must be negative for pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria are not allowed to be enrolled:\n\n1. Patients with head and neck tumor who are indicated for locoregional radical treatment;\n2. Patients with primary nasopharyngeal carcinoma;\n3. Imaging examination shows that the tumor has invaded or surrounded the large blood vessels of the chest, neck, and pharynx, and there is imaging evidence that entering the study will induce risks of hemorrhage;\n4. History of any second malignancy within 2 years prior to randomization, ;\n5. History of adverse events leading to permanent discontinuation of immunotherapy, or occurrence of ≥ Grade 2 immune-related pneumonitis or myocarditis during prior immunotherapy;\n6. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n7. Patients who have newly diagnosed or clinically symptomatic brain or leptomeningeal metastases, spinal cord compression, or cancerous meningitis, or uncontrolled brain or spinal cord metastases that have been evidenced;\n8. Patients with previous or current interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, or severe lung function impairment that may interfere with the detection and management of suspected drug-related pulmonary toxicity; patients with radiation pneumonitis within 6 months;\n9. Patients with any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg after active treatment);\n10. Patients with active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to randomization;\n11. Patients who have used potent CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization;\n12. Patients who have received systemic corticosteroids (prednisone \\> 10 mg\u002Fd or equivalent dose of similar drug) or other immunosuppressants within 2 weeks prior to randomization;\n13. Patients with known active or suspected autoimmune diseases;\n14. Patients who have received live vaccine or live attenuated vaccine within 4 weeks prior to randomization;\n15. Patients who are known to have severe anaphylaxis to macromolecular protein preparations\u002Fmonoclonal antibodies or are allergic to any component in the formulation of the investigational product;\n16. Patients with active tuberculosis;\n17. Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or history of organ transplantation;\n18. Patients with active HBV or HCV infection or HBV\u002FHCV co-infection;\n19. Pregnant or lactating women;\n20. Patients who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator；\n21. Prior treatment with any medication targeting topoisomerase I, including chemotherapy or ADCs;\n22. Radical radiation therapy within 3 months prior to randomization.",{"count":452,"type":22},167,[51],"The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)",[456],"Carcinoma of Head and\u002For Neck","2026-03-03",{"date":437,"type":33},{"date":460,"type":33},"2025-04-22",{"date":462,"type":22},"2029-01-30",{"name":38,"class":39},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":471,"targetDuration":4,"studyType":23,"phases":473,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":214},"100614070","early-phase-1-a-phase-i-study-to-evaluate-the-safety-tolerability-and-pk-of-hlx37-in-advancedmetastatic-solid-tumors-100614070","NCT07274813","A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced\u002FMetastatic Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX37 (Recombinant Human Bispecific Antibodies Against PD-L1 and VEGF) in Patients With Advanced\u002FMetastatic Solid Tumors","Selection criteria\n\n* Before the trial, fully understand the content, process and possible adverse reactions of the trial, sign the informed consent form, voluntarily participate in the trial, and be able to complete the research in accordance with the requirements of the trial protocol.\n* At the time of signing the ICF, the applicant must be at least 18 years old and no more than 75 years old, with no gender restrictions.\n* part 1 of Stage Ia enrolled subjects with advanced or metastatic solid tumors confirmed by histology or cytology, who had failed at least one standard systemic treatment in the advanced or metastatic stage of the disease (subjects who had received neoadjuvant or adjuvant therapy, if disease progression or recurrence occurred within 6 months after the end of treatment) Then this treatment plan will be regarded as a failure of standard treatment, or there is currently no effective standard treatment method.\n\nPart 2 of stage Ia enrollment confirmed by histology or cytology Locally advanced (stage ⅢB\u002FⅢC) or metastatic (stage IV) NSCLC that is not suitable for radical treatment (complete surgical resection, concurrent\u002Fsequential chemoradiotherapy) (according to the 8th edition of lung cancer TNM staging by the Union for International Cancer Control and the American Joint Committee on Cancer AJCC), and should meet the following criteria:\n\nSubjects without targeted driver gene alterations (AGA) :\n\nFor non-squamous NSCLC subjects, there must be previous test results confirming negative EGFR and ALK gene alterations. If there are no previous EGFR and ALK test results, the subjects are required to undergo relevant tests at the research center. For subjects with squamous NSCLC, if the previous EGFR and\u002For ALK gene status is unknown, corresponding tests are not required before enrollment in this study.\n\nThere are no known alterations in the targeted driver genes of ROS1, NTRK, BRAF, METexon 14 skipping or RET.\n\n· Has not received systematic anti-tumor treatment 2) Subjects with AGA: There must be previous test results confirming the existence of one or more targeted driver gene alterations.\n\nPrevious failure of at least one line of standard treatment should include at least targeted therapy for driver gene alterations (patients with EGFR mutations must be treated with EGFR inhibitors).\n\nFor stage Ib, sensitive advanced solid tumor types will be selected for exploration based on the results of stage Ia.\n\n* Within 4 weeks before the first administration, at least one measurable lesion was present according to the efficacy evaluation criteria of RECIST 1.1. For patients who have received radiotherapy before, if the lesion can be measured according to RECIST v1.1 and there is objective evidence proving significant progression after radiotherapy, the lesion that has undergone radiotherapy can be regarded as the target lesion. Brain metastases cannot be used as target lesions.\n* Seven days before the first administration, the ECOG physical strength score is 0-1.\n* The expected survival period exceeds 3 months;\n* Before the first study of drug administration, there must be an interval of at least 28 days from previous major surgical operations, medical device treatment, local radiotherapy (except palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy or biologics treatment. There should be at least a 14-day interval from previous small molecule targeted drug therapy and hormone therapy. There should be at least a 7-day interval from traditional Chinese medicine treatment or minor surgery with anti-tumor indications. And the AE caused by the treatment recovered to CTCAE v5.0 ≤ grade 1 (excluding alopecia);\n* The subject agrees to provide archived tumor tissue specimens that meet the testing requirements (from the most recent surgery or biopsy, preferably within 2 years) or agrees to undergo biopsy to collect tumor tissue for PD-L1 expression testing; Note: The subjects are required to provide tumor samples (paraffin blocks or unstained sections, which must meet the quality control standards for testing) collected from non-radiotherapy sites during or after the diagnosis of malignant tumors and treated with formalin-fixed paraffin embedding (FFPE), as well as the relevant pathological reports of the above specimens.\n* Laboratory tests within 7 days before the first administration of the study confirmed adequate organ function (no blood transfusion or granulocyte colony-stimulating factor was received within 14 days before the first administration) :\n* The Child-Pugh score of the subjects with hepatocellular carcinoma must be A.\n* Male and female subjects of fertility must agree to use at least one highly effective contraceptive method for contraception during the trial and for at least six months after the last administration of the study drug. Female subjects of childbearing age must have a negative pregnancy test result within 7 days prior to enrollment.\n\nExclusion criteria\n\nSubjects who meet any of the following criteria will not be eligible for this study:\n\n* There should be a history of other malignant tumors within 3 years prior to the first medication, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin.\n* There have been adverse events in the past that led to the permanent termination of immunotherapy; Or there was a history of grade ≥2 immune-related pneumonia or immune-related myocarditis;\n* Has a history of (non-infectious) interstitial lung disease (ILD), and currently still requires steroid drug treatment; Or currently having active ILD, or suspected through imaging researchers at the time of screening that there is a risk of ILD aggravation or that they are not suitable to participate in this study;\n* It is known that the subject has had a severe allergic reaction to macromolecular protein preparations\u002Fmonoclonal antibodies in the past, or is allergic to the components of the test drug preparation;\n* Within two weeks before the first medication, there is an active systemic infectious disease that requires intravenous antibiotic treatment;\n* The subjects have poorly controlled clinical symptoms or diseases of the cardiovascular and cerebrovascular system, including but not limited to: (1) NYHA grade II or above heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) Unstable angina pectoris; (3) Has experienced myocardial infarction or cerebrovascular accident within 6 months (excluding lacunar infarction, mild cerebral ischemia or transient ischemic attack); (4) Poorly controlled arrhythmias (including QTc intervals of ≥ 450 ms in men and ≥ 470 ms in women) (QTc intervals are calculated using the Fridericia formula);\n* Subjects who had experienced the following diseases within 12 months prior to the first administration: a history of lower esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, abdominal abscess or a history of acute gastrointestinal bleeding; Subjects who have experienced the following diseases within 6 months prior to the first administration: any arterial thromboembolic event, NCI CTCAE V.5.0 grade 3 or higher venous thromboembolism, transient ischemic attack, cerebrovascular accident, hypertensive crisis or history of hypertensive encephalopathy, subjects with history of acute exacerbation of chronic obstructive pulmonary disease; Patients currently suffering from hypertension with a systolic blood pressure of ≥160 MMHG or a diastolic blood pressure of ≥100 MMHG after oral antihypertensive drug treatment.\n* Known to have meningeal metastasis, or uncontrolled or symptomatic central nervous system (CNS) metastasis, manifested as clinical symptoms, cerebral edema, spinal cord compression and\u002For progressive growth. Subjects with a history of central nervous system metastasis or spinal cord compression who have clearly received treatment and have been determined by the investigator to have stable clinical manifestations after discontinuing anticonvulsants and steroids for 8 weeks before the start of the study treatment can be enrolled in the study. Untreated, asymptomatic subjects with brain metastases (i.e., those without neurological symptoms, no need for corticosteroid hormones, no long diameter of any brain metastases \\>1.5 cm, and no obvious edema around the brain metastases) can be enrolled. Brain metastases are not regarded as target lesions.\n* There is a known active or suspected autoimmune disease. However, subjects with autoimmune hypothyroidism who have received thyroid hormone replacement therapy are allowed to participate in the study; Allow controlled type 1 diabetes subjects receiving insulin treatment to participate in the study;\n\nSubjects who have received systemic corticosteroids (prednisone \\> 10mg\u002F day or equivalent doses of similar drugs) or other immunosuppressants within 14 days prior to the first administration; Except for the following situations: treatment with topical, ocular, intra-articular, intranasal and inhaled corticosteroids; Short-term use of corticosteroids for preventive treatment in cases such as contrast agents;\n\n* Suffering from active pulmonary tuberculosis;\n* Subjects with a history of severe bleeding tendencies or coagulation disorders; Subjects with clinically significant bleeding symptoms within one month before the first administration, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or expelling ≥1 teaspoon of fresh blood or small blood clots, or only coughing up blood without sputum; those with sputum blood can be included), and epistaxis (excluding epistaxis and bloody reflux mucus); Subjects whose imaging examinations during screening showed that the tumor surrounded important blood vessels or had obvious necrosis and cavities, and the researchers judged that there was a risk of bleeding in participating in the study; Patients with central and cavitary squamous non-small cell lung cancer (according to the researchers' judgment, such patients have a higher risk of bleeding).\n* Currently using or having used aspirin (\\> 325mg\u002F day) or dipyridamole, clopidine, clopidogrel and cilostazole for treatment within 7 days before the first use.\n* Currently in use or under study, full-dose oral or injectable anticoagulant drugs or thrombolytic drugs have been used for therapeutic purposes within 7 days prior to the first administration. Prophylactic anticoagulant therapy is permitted for open intravenous infusion systems, provided that the drug activity is less than 1.5 times the upper limit of normal for the international normalized ratio (INR) and the partial thromboplastin time (APTT) is within the normal range within 14 days prior to the first administration. Prophylactic use of low-molecular-weight heparin (i.e. Enoxaparin 40mg\u002F day) is permitted.\n* Daily administration of non-steroidal anti-inflammatory drugs is required for long-term treatment. Occasional use of NSAIDs is permitted to relieve medical symptoms such as headache or fever\n* In the past, when receiving anti-angiogenic therapy, grade ≥3 toxicity related to anti-angiogenic therapy occurred (except for toxicity such as fever that the researchers considered not to pose a safety risk to the subjects).\n* Have a history of immune deficiency, including a positive test for the human immunodeficiency virus (HIV), or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation;\n* Active HBV or HCV infection or co-infection: If HBsAg (+) and\u002For HBcAb (+), HBV-DNA testing is required. The result must be less than 500 IU\u002FmL or less than 2500 copies\u002FmL or less than the upper limit of normal (ULN) for enrollment. For eligible subjects, if HBV-DNA can be detected, it is recommended that they receive nucleoside anti-hepatitis B virus treatment. If the HCV antibody is (+), HCV-RNA must be tested, and the result must be less than the upper limit of normal value (ULN) for enrollment. Subjects with co-infection of hepatitis B and C should be excluded (with positive HBsAg or HBcAb tests and positive HCV antibody tests).\n* Have received a live vaccine within 28 days prior to the first administration;\n* Pregnant or lactating women;\n* The researcher believes that the subjects have any clinical or laboratory test abnormalities or other reasons that make them unsuitable to participate in this clinical study.\n* Suffering from local or systemic diseases not caused by malignant diseases; Or diseases or symptoms caused by tumors that may lead to higher medical risks and\u002For uncertain survival assessment results, such as neoplastic leukemia-like reactions (white blood cell count \\> 20×109\u002FL), cachexia manifestations (for example, known weight loss of more than 10% within 3 months before screening), etc.",{"count":472,"type":22},254,[474],"EARLY_PHASE1","This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX37 in patients with advanced\u002Fmetastatic solid tumors.",[28,477],"NSCLC",{"date":457,"type":33},{"date":480,"type":33},"2025-12-29",{"date":482,"type":22},"2028-12-30",{"name":38,"class":39},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":507},"100556968","phase-3-a-phase--clinical-study-of-hlx22-in-combination-with-trastuzumab-and-chemotherapy-for-the-treatment-of-gastroesophageal-junction-and-gastric-cancer-100556968","NCT06532006","A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer","A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer","Inclusion Criteria:\n\n1. Male\u002Ffemale who are at least 18 years of age on the day of signing the informed consent.\n2. With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.\n3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.\n4. HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor.\n5. ECOG PS within 7 days before randomization: 0-1.\n6. Expected survival ≥ 6 months.\n7. Had adequate organ function\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors within 2 years before the randomization.\n2. Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n3. Previous treatment with any HER2-target therapy.\n4. Active gastrointestinal bleeding\n5. Presence of central nervous system (CNS) metastases.\n6. Left ventricular ejection fraction (LVEF) \\\u003C 55%.\n7. Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.",{"count":492,"type":22},550,[74],"This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced\u002Fmetastatic adenocarcinoma of the gastric and\u002For gastroesophageal junction (G\u002FGEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).",[496,497,498,499],"Gastroesophageal-junction Cancer","Monoclonal Antibody","Gastric Cancer","HER2-positive Gastric Cancer","2026-02-24",{"date":357,"type":33},{"date":503,"type":33},"2024-11-22",{"date":505,"type":22},"2028-09-01",{"name":38,"class":39},208,{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":515,"targetDuration":4,"studyType":23,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":63},"100620512","phase-1-a-phase-ibii-study-to-evaluate-hlx43-combined-with-hlx07-or-serplulimab-in-patients-with-advanced-or-metastatic-colorectal-cancer-100620512","NCT07358585","A Phase Ib\u002FII Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer","A Phase Ib\u002FII Study to Evaluate the Efficacy, Safety and Tolerance of HLX43 (an Anti-PD-L1 Antibody Conjugated) Combined With HLX07 (a Recombinant Anti-EGFR Humanized Monoclonal Antibody) or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma; and locally tested and confirmed as a RAS\u002FBRAF wild-type tumor (only for Part 1 );\n2. Previously failed first-line systemic anti-tumor therapy for advanced or metastatic colorectal adenocarcinoma based on a 5-FU regimen, with radiologically documented disease progression.\n\n   Note: For patients who have previously received radical concurrent chemoradiotherapy, neoadjuvant\u002Fadjuvant chemotherapy, or chemoradiotherapy, if disease progression occurred during treatment or within ≤6 months after treatment cessation, it should be considered as first-line treatment failure; if progression occurred beyond 6 months, it should not be considered as first-line treatment failure.\n3. Patients known to have dMMR\u002FMSI-H must have failed treatment containing a PD-1 immune checkpoint inhibitor, with radiologically documented disease progression (only for Part 1);\n4. There must be an interval of at least 4 weeks or 5 half-lives of the drug (whichever is longer) from the first dose of the investigational drug to prior major surgery, medical device treatment, local radiotherapy (except palliative radiotherapy for bone metastases), cytotoxic chemotherapy, macromolecular targeted drug therapy, immunotherapy, or biologic therapy; an interval of at least 2 weeks from prior small molecule targeted drug therapy; an interval of at least 1 week from prior traditional Chinese medicine therapy with anti-tumor indications or minor surgery; and all prior anti-tumor treatment-related adverse events (AEs) must have recovered to CTCAE v5.0 Grade ≤1 (except peripheral neuropathy and alopecia).\n5. Adequate organ function.\n\nExclusion Criteria:\n\n1. Prior exposure to any drug targeting topoisomerase I, including chemotherapy or antibody-drug conjugates (ADCs); prior treatment with anti-EGFR antibody therapy (only for Part 1); prior treatment with PD-1\u002FPD-L1 inhibitors or any immunotherapy targeting immune checkpoints (only for Part 2).\n2. Candidates suitable for locoregional treatment with curative intent (e.g., surgery or radiotherapy).\n3. History of a second malignant neoplasm within 2 years prior to randomization, except for early-stage malignancies treated with curative intent (e.g., carcinoma in situ or Stage I tumors), such as non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, ductal carcinoma in situ of the breast, or papillary thyroid cancer.\n4. Known or suspected history of keratitis, ulcerative keratitis, or severe dry eye disease.\n5. History of adverse events leading to permanent discontinuation of prior immunotherapy; or history of ≥ Grade 2 immune-mediated pneumonitis or immune-mediated myocarditis.\n6. Use of strong inhibitors or inducers of CYP2D6 or CYP3A within 2 weeks prior to randomization.\n7. Active HBV or HCV infection or co-infection",{"count":516,"type":22},126,[25,51],"This study is a phase Ib\u002FII study to evaluate the efficacy, safety and tolerance of HLX43 combined with HLX07 or Serplulimab in patients with advanced or metastatic colorectal cancer failed or intolerance to standard first-line therapy",[520],"Colon Cancer Adenocarcinoma","2026-01-14",{"date":523,"type":33},"2026-01-22",{"date":525,"type":22},"2026-01-31",{"date":527,"type":22},"2028-08-23",{"name":38,"class":39},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":546,"leadSponsor":548,"locationsCount":63},"100617458","phase-2-a-phase-iiiii-clinical-study-to-evaluate-hlx07-in-combination-with-serplulimab-and-chemotherapy-versus-placebo-in-combination-with-serplulimab-or-pembrolizumab-and-chemotherapy-as-first-line-treatment-in-advanced-squamous-non-small-cell-lung-cancer-100617458","NCT07318883","A Phase II\u002FIII Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer","A Randomized, Double-Blind, Multicenter, Phase II\u002FIII Clinical Study to Evaluate HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Patients With Advanced Squamous Non-Small Cell Lung Cancer (sqNSCLC)","Inclusion Criteria:\n\n1. The patients voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the informed consent form (ICF), and are willing to follow and able to complete all study procedures.\n2. Male or female, aged 18 years or older at the time of signing the ICF.\n3. Histologically confirmed with stage IIIB\u002FIIIC or IV (AJCC 8th edition) squamous NSCLC ineligible for surgery or radical radiotherapy.\n4. Patients must provide sufficient tumor tissues that meet the quality requirements for the determination of EGFR and PD-L1 expression levels.\n\n   Note: Formalin-fixed tumor samples (paraffin blocks or unstained sections, meeting the quality control criteria for testing) collected from lesions that have not received radiotherapy at or after the diagnosis of locally advanced\u002Frecurrent or distant metastatic squamous non-small cell lung cancer (sqNSCLC) (from the most recent surgery or biopsy, preferably within half a year prior to randomization) should be provided. Relevant pathology reports must also be provided for the above specimens. For detailed requirements for tissue samples, see the Laboratory Operation Manual.\n5. Absence of prior systemic treatment for locally advanced\u002Frecurrent or distant metastatic sqNSCLC. Patients who have received prior adjuvant or neoadjuvant therapy are allowed to be enrolled if the adjuvant\u002Fneoadjuvant therapy has been completed at least 6 months before the diagnosis of locally advanced\u002Frecurrent or distant metastatic sqNSCLC.\n6. Prior non-systemic anti-tumor therapy or Chinese herbal anti-tumor therapy must have ended for ≥ 2 weeks before randomization, and treatment-related AEs have resolved to Grade ≤ 1 according to Common Terminology Criteria for Adverse Events (CTCAE) 6.0 (except for Grade 2 alopecia).\n7. At least one measurable target lesion assessed by BICR as per RECIST v1.1 within 4 weeks before randomization.\n\n   Note: Measurable target lesions cannot be selected from prior radiotherapy sites. A lesion at the prior radiotherapy site may be selected as the target lesion if it is the only available lesion, and should provide the imaging data of the lesion before and after an unequivocal progression after the radiotherapy.\n8. An ECOG performance status score of 0 or 1 within 7 days prior to randomization.\n9. Life expectancy ≥ 12 weeks.\n10. Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-); if HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be \\\u003C 2,500 copies\u002FmL or 500 IU\u002FmL or within the normal range of this site.\n11. HCV antibody (-); if HCV antibody (+), HCV-RNA testing must be negative before enrollment. Participants co-infected with hepatitis B and C will be excluded (tested positive for HBsAg or HBcAb and positive for HCV antibody).\n12. Adequate major organ functions as defined by the following criteria\n13. Female patients must meet one of the following conditions:\n\n    * Post-menopausal (defined as amenorrhea for at least 1 year with no documented cause other than menopause), or\n    * Surgically sterilized (removal of the ovaries and\u002For uterus), or\n    * Fertile, but must:\n\n      * be tested negative for serum pregnancy test within 7 days prior to randomization, and\n      * agree to use contraception with an annual failure rate of \\\u003C 1% or to remain abstinent (avoid heterosexual intercourse) from signing the informed consent form to at least 6 months after the last dose of study drugs (contraception with an annual failure rate of \\\u003C 1% includes bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper-containing intrauterine devices), and not donate eggs during this period, and\n      * not breastfeed.\n14. Male patients must: agree to remain abstinent (avoid heterosexual intercourse) or take contraception measures as follows: male patients with a pregnant partner or a partner with childbearing potential must remain abstinent or take contraception measures for contraception during the treatment period with the study drugs and for at least 6 months after the last dose to prevent the drug exposure to the embryo. Periodic abstinence (e.g., contraception based on calendar day, ovulatory phase, basal body temperature, or postovulatory phase) and external ejaculation are ineligible methods of contraception. Sperm donation is prohibited during this period.\n15. Patients who have previously received denosumab and are eligible for and agree to switch to bisphosphonates for bone metastases.\n\nExclusion Criteria:\n\n1. Histologically confirmed non-sqNSCLC. Mixed tumors will be classified by the predominant cell type. Patients with small cell component or neuroendocrine carcinoma component are not eligible. For the non-small cell histology, patients with squamous component that is predominant (e.g., adenosquamous) are eligible.\n2. Known EGFR-sensitizing mutation, ALK\u002FROS1 gene rearrangement, or other actionable driver oncogenes for which there are locally approved targeted first-line therapies.\n\n   Note: If the EGFR, ALK, ROS1 and other actionable driver oncogenes statuses are unknown, testing is not mandatory, unless there are high-risk factors (such as non-smoking female patients), under which circumstances testing of EGFR and other mutations may be considered.\n3. Other malignancies within 5 years or active. Patients with localized tumors that have been cured, such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast cancer in situ, are eligible.\n4. Scheduled or previous organ or bone marrow transplantation.\n5. Uncontrollable pleural effusion, pericardial effusion, or ascites.\n6. Active central nervous system (CNS) metastases and\u002For carcinomatous meningitis known or diagnosed at screening. However, the following patients may be enrolled:\n\n   * Patients with asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain metastases, no requirement for glucocorticoid therapy, and lesion size ≤ 1.5 cm) may be enrolled, but are required to receive regular brain imaging as a site of lesion.\n   * Patients with treated brain metastases that have been stable for at least 1 month, with no evidence of new or enlarging brain metastases, and with glucocorticoid discontinued ≥ 3 days prior to randomization.\n\n   Stable brain metastases should be confirmed before randomization.\n7. Spinal cord compression that has not been cured with radical surgery and\u002For radiotherapy.\n8. Clinically significant hemoptysis complicated with superior vena cava syndrome.\n9. Myocardial infarction and poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia's formula) within 6 months prior to randomization;\n10. NYHA Class III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF) \\\u003C 50% by echocardiography.\n11. Inadequately controlled hypertension (defined as systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg), with a history of hypertensive crisis or hypertensive encephalopathy.\n12. Grade ≥ 2 peripheral neuropathy as per CTCAE 6.0.\n13. Human immunodeficiency virus (HIV) infection.\n14. Active pulmonary tuberculosis.\n15. A history of or active interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe lung function impairment that may interfere with the detection and management of suspected drug-related pulmonary toxicity.\n16. Known active or suspected autoimmune diseases. Patients with a history of autoimmune disease that does not require systemic immunosuppressive therapy for at least 12 months prior to screening are allowed to be enrolled.\n17. Treatment with live vaccines within 28 days prior to randomization. Inactivated seasonal influenza vaccines and COVID-19 vaccines are allowed, but live attenuated influenza vaccines for intranasal use are not allowed.\n18. Treatment with systemic glucocorticoids (\\> 10 mg\u002Fday prednisone efficacy dosage) or other immunosuppressive drugs required within 14 days prior to randomization or during the study. However, patients are allowed to be enrolled under the following conditions: in the absence of active autoimmune disease, patients are allowed to use topical or inhaled glucocorticoids and adrenal glucocorticoid replacement therapy at a dose equivalent to ≤ 10 mg\u002Fday of prednisone efficacy.\n19. Any active infection requiring systemic anti-infective therapy or use of systemic anti-infective therapy within 14 days prior to randomization.\n20. Major surgery within 28 days prior to randomization; major surgery in this study is defined as any surgery that requires at least 3 weeks of postoperative recovery time before receiving the study treatment. Patients with a history of tumor needle biopsy or lymph node incisional biopsy are allowed to be enrolled.\n21. Radical radiotherapy within 3 months prior to randomization. Note: Palliative radiotherapy to bone or palliative radiotherapy to superficial lesions is allowed according to the local treatment guidelines, which should have been completed 2 weeks prior to randomization. Radiotherapy covering more than 30% of the bone marrow area within 28 days prior to randomization is not allowed.\n22. Prior use of other antibodies\u002Fdrugs against immune checkpoints, such as PD-1, PD-L1, CTLA4, etc. Patients with prior systemic anti-EGFR monoclonal antibody therapy.\n23. Current participation in any other clinical study, or the end of the previous clinical study treatment is less than 14 days apart from the planned start of the study treatment in this study.\n24. Known history of severe allergy to any monoclonal antibody.\n25. Known allergy to any components of carboplatin or paclitaxel (or nab-paclitaxel).\n26. Pregnant or lactating women.\n27. Known history of psychotropic abuse or drug abuse; history of alcohol abuse.\n28. Presence of any other factors that may lead to a premature study discontinuation as judged by the investigator.",{"count":537,"type":22},720,[51,74],"The study consists of two parts:\n\nPart I is a randomized, double-blind, multicenter, parallel-controlled phase II clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with serplulimab and chemotherapy as first-line treatment in patients with sqNSCLC.\n\nPart II is a randomized, double-blind, multicenter, parallel-controlled phase III clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy as first-line treatment in patients with sqNSCLC.",[541],"Squamous NSCLC","2026-01-04",{"date":544,"type":33},"2026-01-06",{"date":395,"type":22},{"date":547,"type":22},"2031-01",{"name":38,"class":39},""]