[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advancedmetastatic-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advancedmetastatic-solid-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,40,61,82,105,131,188,209,230,253,277,298,328],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Advanced\u002FMetastatic Solid Tumors","RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":29,"type":32},{"date":35,"type":21},"2028-08",{"name":37,"class":38},"Shanghai Henlius Biotech","INDUSTRY",7,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},"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":48,"type":21},41,[24],"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.",[27],"2026-05-25",{"date":54,"type":32},"2026-05-28",{"date":56,"type":32},"2026-05-22",{"date":58,"type":21},"2029-06-01",{"name":37,"class":38},5,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100586974","phase-1-a-phase-iii-of-hrs-6719-in-patients-with-advancedmetastatic-solid-tumors-100586974","NCT06922357","A Phase I\u002FII of HRS-6719 in Patients With Advanced\u002FMetastatic Solid Tumors","A Phase I\u002FII, Open-label, Multi-centre Study Evaluating the Safety,Tolerability,Pharmacokinetic (PK), Pharmacodynamics, and Preliminary Efficacy of HRS-6719 in Patients With Advanced\u002FMetastatic Solid Tumors With MTAP Deficiency","Inclusion Criteria:\n\n1. Subjects must voluntarily participate in the study and sign an informed consent form;\n2. Aged 18-75 years, male or female eligible；\n3. ECOG performance status score of 0-1；\n4. Expected survival ≥12 weeks；\n5. Patients with histologically or cytologically confirmed advanced malignant solid tumors who meet one of the following criteria:Disease progression or intolerance after receiving adequate standard therapy; Lack of standard treatment options;Currently ineligible for standard therapy；\n6. Ability to provide sufficient fresh or archived tumor tissue specimens；\n7. Adequate function of vital organs；\n8. Effective contraception must be used during the trial. For women of childbearing potential, a negative pregnancy test within 7 days prior to the first dose is required。\n\nExclusion Criteria:\n\n1. History of other malignant tumors within the past 5 years；\n2. Received systemic anti-tumor therapy within 4 weeks prior to the first study dose.\n3. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 4 weeks before the first administration, diagnostic or surface surgery was performed within 1 week before the first administration, or elective surgery was expected during the trial.\n4. The study received radical radiotherapy within 4 weeks before the first medication ; and received palliative radiotherapy within 2 weeks before the first medication.\n5. Uncontrolled pleural, pericardial, or peritoneal effusions.\n6. Severe cardiac diseases occurring within 6 months prior to the first dose.\n7. Arterial\u002Fvenous thrombosis within 6 months before the first dose.\n8. Clinically significant bleeding symptoms or predisposition within 3 months prior to the first dose.\n9. Active infection or fever of unknown origin \\> 38.5 ° C was present within 4 weeks before the first administration of the study\n10. History of immunodeficiency.\n11. Active hepatitis B or C.\n12. Diseases affecting drug absorption\u002Ftransport (e.g., malabsorption syndromes).\n13. A history of severe allergic reactions to HRS-6719 and its main components was known or suspected, or there was a history of delayed allergic reactions, eczema or asthma that could not be controlled by topical corticosteroids.\n14. Use of strong CYP3A4\u002FP-gp inhibitors\u002Finducers within 5 half-lives before the first dose.\n15. Adverse events (AEs) from prior anti-tumor therapy not resolved to CTCAE v5.0 ≤ Grade 1.\n16. Patients with interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or clinically significant pulmonary fibrosis, persistent pneumonia, pneumonia caused by drug or radiotherapy, congenital pneumonia, or chest CT scan found any evidence of active pneumonia.\n17. Through medical history or CT examination, it was found that there was active pulmonary tuberculosis infection within 1 year before enrollment, or more than 1 year ago, there was a history of active pulmonary tuberculosis infection but no formal treatment.\n18. Live attenuated vaccines administered within 4 weeks before the first dose or planned during the study.\n19. Other factors potentially compromising study safety or data integrity.",{"count":69,"type":21},120,[24,71],"PHASE2","This is a Phase I\u002FII, multicenter, open-label clinical trial with dose escalation\u002Fdose expansion\u002Fefficacy expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profiles, and antitumor efficacy characteristics of HRS-6719 in patients with MTAP-deficient advanced solid tumors.",[27],{"date":54,"type":32},{"date":76,"type":32},"2025-04-24",{"date":78,"type":21},"2027-12",{"name":80,"class":38},"Shandong Suncadia Medicine Co., Ltd.",2,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100494493","phase-1-a-study-of-atg-022-in-patients-with-advancedmetastatic-solid-tumors-100494493","NCT05718895","A Study of ATG-022 in Patients With Advanced\u002FMetastatic Solid Tumors","An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced\u002FMetastatic Solid Tumors","CLINCH","Inclusion Criteria:\n\n1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.\n2. Aged at least 18 years as of the date of consent.\n3. Histological or cytological confirmation of a solid tumor, and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or not applicable for standard therapy(ies).\n\n   1. Dose Escalation Phase: all solid tumors.\n   2. Dose Expansion Phase: Claudin 18.2 positive solid tumors.\n4. Subjects should be willing to receive a biopsy at screening, if no former available tumor tissue samples within 36 months prior to participating in the study are provided.\n5. At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.\n6. Estimated life expectancy of a minimum of 12 weeks.\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 .\n8. Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding, and must have a negative pregnancy test prior to the start of dosing if of child-bearing potential or must have evidence of nonchild-bearing potential by fulfilling one of the following criteria at screening\n9. Male subjects should be willing to use effective contraception, ie condoms, for the duration of the study and 180 days after the final dose of study treatment.\n\nExclusion Criteria:\n\n1. Primary central nervous system disease or central nervous system metastatic disease.\n2. Prior exposure to a Claudin 18.2 targeting agent.\n3. Prior therapy with any chemotherapy, immunotherapy, anticancer agents, or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (eg, a period of 5 'half-lives'.\n4. Prior vaccination within 28 days of the first dose of study therapy.\n5. Prior any solid organ transplant. Autologous stem cell transplant or CAR-T cell infusion \\\u003C 6 months prior to the first dose of study treatment.\n6. Active infection including hepatitis B, and\u002For hepatitis C.\n7. Known history of human immunodeficiency virus (HIV) infection.\n8. Any unresolved toxicities from prior therapy greater than Grade 1 at the time of ICF signature, with the exception of alopecia.\n9. Pregnant or nursing females.\n10. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-022.\n11. Other primary malignancies developed within 5 years prior to the first dose of the study drug, except locally curable malignancies after radical treatment .\n12. In the opinion of the investigator, subject's complications, or other conditions (psychological, familial, sociological, or geographical etc.) may affect protocol compliance or may be unsuitable for participation in the study.",{"count":91,"type":21},156,[24],"This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced\u002Fmetastatic Solid Tumors",[27],"2026-04-10",{"date":97,"type":32},"2026-04-15",{"date":99,"type":32},"2023-03-27",{"date":101,"type":21},"2027-12-30",{"name":103,"class":38},"Antengene Biologics Limited",22,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100603837","phase-1-a-study-of-db-1317-in-selected-advancedmetastatic-solid-tumors-100603837","NCT07141706","A Study of DB-1317 in Selected Advanced\u002FMetastatic Solid Tumors","A Phase 1a\u002F1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants With Selected Advanced\u002FMetastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Male or female adults\n2. Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments.\n3. Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants.\n4. Has a life expectancy of ≥ 3 months.\n5. Has an ECOG PS of 0-1.\n6. Has LVEF ≥ 50% within 28 days before enrollment.\n7. Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of ADAM9 expression level and other biomarkers if no contra-indication.\n8. Male and female participants of reproductive\u002Fchildbearing potential must agree to use adequate contraceptive methods\n\nKey Exclusion Criteria:\n\n1. Prior treatment with ADAM9 targeted therapy.\n2. Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor.\n3. Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment.\n4. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.\n5. Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG\n6. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \\> 470 ms in males and females\n7. Has a history of (non-infectious) ILD\u002Fpneumonitis\n8. Has a lung-specific intercurrent clinically significant illness\n9. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.\n10. Known human immunodeficiency virus (HIV) infection;Chronic, active, or uncontrolled hepatitis B;\n11. Known chronic, active, or uncontrolled hepatitis C\n12. Has clinically significant corneal disease.\n13. Has clinically active brain metastases\n14. Has unresolved toxicities from previous anticancer therapy Concurrent malignancy \\\u003C 3 years.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":113,"type":21},233,[24],"This is a multicenter, open-label, multiple-dose, FIH Phase 1a\u002F1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes up to 3 randomized dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.",[27],[118,119,120],"ADAM9","Solid tumor","DB-1317","2026-04-07",{"date":123,"type":32},"2026-04-09",{"date":125,"type":32},"2025-09-23",{"date":127,"type":21},"2028-06",{"name":129,"class":38},"DualityBio Inc.",6,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":155,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100599900","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-08046876-in-people-with-advanced-solid-tumors-100599900","NCT07090499","A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors","A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas\n* Measurable disease\n* ECOG Performance status 0-1\n* Part 1: progression or relapse following standard treatments\n* Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting\n* Resolution of acute effects of prior anticancer therapy to baseline or Grade 1\n* Consent to submit required pre-treatment tumor tissue as medically feasible\n\nExclusion criteria:\n\n* Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )\n* Active anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction meeting protocol exclusion\n* Pulmonary disease meeting protocol exclusion\n* Other unacceptable abnormalities as defined by protocol",{"count":139,"type":21},310,[24],"The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.\n\nThe study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.",[27,143,144,145,146,147,148,149,150,151,152,153,154],"Bladder Cancer","Urothelial Carcinoma","Advanced Non-Small Cell Lung Cancer","Carcinoma, Non Small Cell Lung","Carcinoma, Squamous Cell of Head and Neck","Head and Neck Cancer","Esophageal Cancer","Gastroesophageal Junction Adenocarcinoma","Esophageal Squamous Cell Carcinoma","Esophageal Adenocarcinoma","Pancreatic Adenocarcinoma","Pancreatic Cancer",[156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178],"B6C","integrin beta 6","ADC","antibody drug conjugate","bladder cancer","urothelial carcinoma","non-small cell lung cancer","NSCLC","head and neck cancer","HNSCC","SCCHN","esophageal cancer","EC","esophageal squamous cell carcinoma","gastroesophageal junction adenocarcinoma","pancreatic cancer","PDAC","pancreatic adenocarcinoma","esophageal adenocarcinoma","lung adenocarcinoma","lung squamous cell carcinoma","integrin alpha-v beta-6 receptor","ITGB6","2026-04-06",{"date":121,"type":32},{"date":182,"type":32},"2025-08-20",{"date":184,"type":21},"2029-07-08",{"name":186,"class":38},"Pfizer",28,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":208,"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":197,"type":21},138,[24],"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.",[27],"NOT_YET_RECRUITING","2026-03-13",{"date":204,"type":32},"2026-03-18",{"date":206,"type":21},"2026-03",{"date":127,"type":21},{"name":37,"class":38},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":81},"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":217,"type":21},254,[219],"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.",[27,163],"2026-02-27",{"date":224,"type":32},"2026-03-03",{"date":226,"type":32},"2025-12-29",{"date":228,"type":21},"2028-12-30",{"name":37,"class":38},{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":237,"minAge":17,"maxAge":18,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100624917","phase-1-phase-1ii-clinical-study-of-sys6043-in-the-treatment-of-advancedmetastatic-solid-tumors-100624917","NCT07415863","Phase 1\u002FII Clinical Study of SYS6043 in the Treatment of Advanced\u002FMetastatic Solid Tumors","Phase I\u002FII Dose-Escalation, PK Expansion and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SYS6043 in Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Aged 18 to 75 years inclusive (based on the date of signing the informed consent form). For Cohort 2 and Cohort 10, subjects over 75 years of age are eligible for enrollment.\n2. Histologically or cytologically confirmed advanced\u002Funresectable or metastatic solid tumors with disease recurrence or progression during or after standard systemic therapy, intolerance to standard therapy, or no available standard therapy.\n3. At least one extracranial measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). For participants with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases only, eligibility for enrollment will be determined following a discussion and assessment with the sponsor's medical monitor on a case-by-case basis.\n4. Expected survival of the participant is ≥ 3 months.\n5. ECOG performance status of 0 or 1 with no deterioration in status identified within 28 days prior to enrollment. For Cohort 2 and Cohort 10, subjects with an ECOG performance status of 2 are eligible for enrollment.\n6. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography (ECHO) or radionuclide ventriculography (MUGA) within 28 days prior to enrollment.\n7. Adequate function of major organs meeting the following requirements within 7 days prior to enrollment:\n\n   1. Hematology (no receipt of whole blood, red blood cell or platelet transfusion, and no administration of hematopoietic stimulating factors \\[G-CSF or GM-CSF\\], erythropoietin \\[EPO\\] or thrombopoietin \\[TPO\\] for cytorection within 7 days prior to sample collection):Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL;Platelet count (PLT) ≥ 100×10⁹\u002FL;Hemoglobin (HGB) ≥ 90 g\u002FL.\n   2. Blood biochemistry:Serum creatinine ≤ 1.5×upper limit of normal (ULN);Serum total bilirubin (TBIL) ≤ 1.5×ULN (may be relaxed to 3×ULN for participants with Gilbert's syndrome);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5.0×ULN for participants with hepatocellular carcinoma or liver metastases);Serum albumin ≥ 30 g\u002FL.\n   3. Coagulation function:Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (for participants not receiving anticoagulant therapy); for participants receiving anticoagulant therapy, indices shall be within the therapeutic target range with a stable dosage.\n8. Toxic reactions caused by any prior therapy have recovered to ≤ Grade 1 per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or baseline levels (except for alopecia, fatigue, peripheral neuropathy and other toxicities that the investigator deems to pose no safety risk to the participant).\n9. Sufficient washout period for prior anti-tumor therapies before the first study drug administration.\n10. Be willing to provide previously resected tumor samples or undergo a fresh tumor biopsy for the detection of B7-H3 expression levels and other biomarkers (if there are no contraindications).\n11. For female participants of childbearing potential, the serum pregnancy test result within 7 days prior to randomization must be negative. Male and female participants with reproductive potential must agree to adopt adequate contraceptive measures during the study period and for at least 7 months after the last administration of the study drug; during this period, female participants must not be breastfeeding, male participants must not freeze or donate sperm, and female participants must not donate or retrieve oocytes for personal use.\n12. Have a full understanding of this clinical trial and voluntarily sign a written informed consent form\n13. Advanced or metastatic solid tumors with failure of standard systemic therapy\n\nExclusion Criteria:\n\n1. Prior receipt of B7-H3-targeted therapy.\n2. Prior receipt of irinotecan, topotecan, any other topoisomerase I inhibitors (including investigational TOP1 inhibitors), or topoisomerase inhibitor antibody-drug conjugates (e.g., trastuzumab deruxtecan). This criterion applies only to the Phase I PK expansion and Phase II cohort expansion stages.\n3. A history of symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II-IV) or severe cardiac arrhythmias requiring treatment.\n4. A history of myocardial infarction or unstable angina within 6 months prior to enrollment.\n5. A prolonged corrected mean QT interval (QTcF) using the Fredericia formula of \\>470 milliseconds (ms) on three 12-lead electrocardiogram (ECG) assessments, for both male and female participants.\n6. Inability or unwillingness to discontinue concomitant medications known to prolong the QT interval.\n7. A history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring glucocorticoid therapy, current ILD\u002Fnon-infectious pneumonia, or suspected such disease on imaging during screening.\n8. A history of underlying pulmonary disease, including but not limited to pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, and other clinically significant pulmonary impairment within 3 months prior to the start of study treatment, or the need for supplemental oxygen.\n9. Any autoimmune, connective tissue, or inflammatory disease involving the lungs that is documented or suspected during screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).\n10. Uncontrolled infection requiring intravenous antibiotics, antiviral agents, or antifungal agents.\n11. Known human immunodeficiency virus (HIV) infection, or currently active syphilis infection (i.e., positive Treponema pallidum antibody \\[RPR or TRUST\\] or syphilis requiring systemic therapy).\n12. Participants with active viral hepatitis (positive hepatitis B surface antigen \\[HBsAg\\] and\u002For positive hepatitis B core antibody \\[anti-HBc\\] with HBV DNA ≥1000 copies\u002FmL or 2000 IU\u002FmL; positive hepatitis C virus \\[HCV\\] with HCV RNA above the lower limit of quantification \\[LLOQ\\] of the assay).\n13. Lactating women (women willing to temporarily discontinue breastfeeding are also excluded), or women confirmed to be pregnant by pregnancy test within 7 days prior to enrollment.\n14. Presence of spinal cord compression, or clinically active brain or meningeal metastases. Participants with central nervous system (CNS) metastases are eligible if: they have received prior CNS-directed therapy and have had radiological and neurological stability for at least 4 weeks before the first dose (i.e., no new or enlarging metastatic lesions on imaging, no requirement for corticosteroid therapy or maintenance of a stable or tapering dose of corticosteroids \\[equivalent to ≤10 mg\u002Fday prednisone\\], and no symptoms); or they have untreated asymptomatic CNS metastases that the investigator assesses as not requiring immediate treatment.\n15. A history of multiple primary malignant neoplasms within 3 years prior to enrollment, except for: adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer); in situ disease treated with curative intent (e.g., cervical or breast carcinoma in situ); and other solid tumors treated with curative intent (e.g., superficial bladder cancer).\n16. A history of substance abuse, or any other medical condition that the investigator deems may increase the safety risk to the participant or interfere with the participant's participation in or evaluation of the clinical study.\n17. Receipt of strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose of the study drug, or the need for continued use of such medications during the study period.\n18. Known hypersensitivity to the active ingredient or excipients of the study drug.\n19. Presence of pleural, pericardial, or peritoneal effusion with clinical symptoms or requiring repeated drainage.\n20. Any other reason that the investigator deems the participant unsuitable for enrollment in the study","FEMALE",{"count":239,"type":21},820,[24,71],"Phase I\u002FII Clinical Study of SYS6043 in the Treatment of Advanced\u002FMetastatic Solid Tumors This study is a first-in-human phase I\u002FII, multicenter, open-label, dose-escalation trial with PK expansion and cohort expansion, designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted antibody-drug conjugate) in patients with advanced\u002Fmetastatic solid tumors. It consists of three parts: dose escalation, PK expansion and cohort expansion.",[27],"2026-02-10",{"date":245,"type":32},"2026-02-17",{"date":247,"type":32},"2024-12-30",{"date":249,"type":21},"2028-06-30",{"name":251,"class":38},"CSPC Megalith Biopharmaceutical Co.,Ltd.",1,{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":276},"100470418","phase-1-adg126-in-combination-with-pembrolizumab-in-patients-with-advancedmetastatic-solid-tumors-100470418","NCT05405595","ADG126 in Combination With Pembrolizumab in Patients With Advanced\u002FMetastatic Solid Tumors","A Phase 1b\u002F2, Open-Label, Dose Escalation and Expansion Study of ADG126 in Combination With Pembrolizumab (Anti PD-1 Antibody) in Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. ≥18 years of age at the time of informed consent.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n3. Wash out period from previous antitumor therapies\n4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.\n5. Adequate organ function.\n6. An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.\n7. For Dose Escalation Phase Only: Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.\n8. Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding females.\n2. Childbearing potential who does not agree to the use of contraception during the treatment period.\n3. Treatment with any investigational drug within washout period.\n4. Prior treatment with a PD-1, PD-L1 targeting agent or a next-generation anti-CTLA-4 therapy with enhanced ADCC function.\n5. History of significant irAEs or irAE.\n6. Central nervous system (CNS) disease involvement.\n7. History or risk of autoimmune disease.\n8. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\\>10 mg\u002Fday prednisone or equivalent).\n9. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).\n10. Major surgery within 4 weeks prior to the first dose of the study drug.\n11. Has had an allogeneic tissue\u002Fsolid organ transplant.\n12. Has received a COVID-19 vaccine within 7 days prior to the first dose of study treatment. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed.\n13. A positive COVID-19 test within 14 days of Cycle 1 Day 1.\n14. History of Hypersensitivity or known to be allergic to protein drugs or recombinant protein.\n15. Active hemoptysis or central airway invasion by metastatic tumor.",{"count":261,"type":21},186,[24,71],"This is a Phase 1b\u002F2, open-label, dose escalation, dose expansion and dose optimization study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced\u002Fmetastatic solid tumors.\n\nThe study drug ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).",[27],[266],"ADG126-P001","2026-01-06",{"date":269,"type":32},"2026-01-07",{"date":271,"type":32},"2022-06-15",{"date":273,"type":21},"2027-04-30",{"name":275,"class":38},"Adagene Inc",21,{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":252},"100600785","phase-1-study-of-mhb088c-for-patients-with-advanced-solid-malignant-tumors-100600785","NCT07102004","Study of MHB088C for Patients With Advanced Solid Malignant Tumors","A Phase I\u002FII Study of MHB088C for Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;\n* Age ≥ 18 years old when signing the informed consent form;\n* The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\\~1;\n* The expected survival time is at least 3 months;\n* Eligible participants of childbearing potential must agree to take highly reliable contraceptive measures with their partners during the study and within at least 90 days after the last dose and agree not to retrieve, freeze or donate sperm or ova from screening to at least 3 months after the last dose of investigational drug; female participants of childbearing potential must have a negative results of blood pregnancy test before the first dose of investigational drug, and must be non-lactating.\n* Understand study requirements, willing and able to comply with study and follow-up procedures.\n\nNeoplasm-related criteria\n\n* Phase Ia: Histologically or cytologically confirmed unresectable advanced or metastatic malignant solid tumors, that is progressed or intolerant with standard of care (SOC), or for which no SOC regimens are available.\n* Phase Ib: Histologically or cytologically confirmed unresectable advanced or metastatic malignant solid tumors, that is relapsed or progressed following systemic treatment or no SOC is available;\n* Phase II: Histologically or cytologically documented unresectable advanced or metastatic SCLC and previous progressed during or after platinum-contained chemotherapy and immune-checkpoint inhibitors (ICIs).\n\nExclusion Criteria:\n\n* Has more than 2 primary malignancies before signing of Informed Consent Form.\n* Has received anti-tumor treatment before the first dose of investigational product; Medication of traditional Chinese medicine before the first dose of investigational drug.\n* Medication of other unmarketed investigational drugs or therapies before the first dose of investigational drug.\n* Presence of unstable brain metastases and\u002For leptomeningeal carcinomatosis.\n* Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1;\n* Has underwent major organ surgery or significant trauma before the first dose of investigational drug or requiring elective surgery during the study.\n* Has vaccinated with attenuated live vaccines before the first dose of investigational drug.\n* Has mucosal or internal bleeding for non-traumatic reason before the first dose of investigational drug.\n* Has received treatment with systemic corticosteroids or other immunosuppressive agents before the first dose of investigational drug.\n* Has pulmonary disease that severely impact pulmonary function.\n* Has history of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or current ILD\u002Fpneumonia, or suspected ILD\u002Fpneumonia that cannot be excluded by imaging examination at screening.",{"count":285,"type":21},515,[24,71],"This is a Phase I\u002FII, multicenter, open-label clinical trial with dose escalation\u002Fdose expansion\u002Fefficacy expansion phases, designed to evaluate the safety\u002Ftolerability, pharmacokinetics, immunogenicity and preliminary efficacy of MHB088C in participants with advanced solid tumors",[27],"2025-07-28",{"date":291,"type":32},"2025-08-03",{"date":293,"type":32},"2023-06-20",{"date":295,"type":21},"2027-07",{"name":297,"class":38},"Qilu Pharmaceutical Co., Ltd.",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100485932","phase-1-first-in-human-study-of-emb-07-in-locally-advancedmetastatic-solid-tumors-or-relapserefractory-lymphoma-100485932","NCT05607498","First in Human Study of EMB-07 in Locally Advanced\u002FMetastatic Solid Tumors or Relapse\u002FRefractory Lymphoma","A First-in-human, Phase I, Open-Label Study of EMB-07, a Bi-specific Antibody Anti-CD3 and Receptor Tyrosine Kinase-like Orphan Receptor 1 (ROR1) in Patients With Locally Advanced\u002FMetastatic Solid Tumors or Relapse\u002FRefractory Lymphoma","Inclusion Criteria:\n\n1. Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.\n2. Male or female, and aged ≥ 18 years\n3. Treatment group A: Patients with histologically or cytologically locally advanced unresectable or metastatic solid tumors limiting to triple-negative breast cancer, lung adenocarcinoma, ovarian cancer, pancreatic cancer, colorectal cancer, gastric cancer, prostate cancer, bladder cancer, and uterus cancer. Treatment group B: Patients with histologically or cytologically relapse\u002Frefractory lymphoma limiting to chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL).\n4. Treatment group A: Standard therapies do not exist, or are no longer effective, or are not tolerable or accessible to the patient measurable or evaluable disease per RECIST V1.1. Treatment group B: Presence of at least one two-dimensional measurable lesion confirmed by imaging (CT or MRI) (either lymph nodes lesions with any long diameter \\> 1.5 cm or extranodal lesions with any long diameter \\> 1.0 cm); for CLL patients whose baseline imaging evaluation determined that no two-dimensional measurable lesions, their peripheral blood monoclonal B lymphocytes should be ≥ 5.0×109\u002FL.\n5. Patients must provide archival tumor samples, or a biopsy will be required if archival tumor sample is not available. Archival tumor sample must be taken ≤ 2 years prior to screening, otherwise a fresh tumor biopsy at screening is required.\n6. ECOG performance status 0 or 1\n7. Adequate organ function to participate in the trial.\n8. Recovery from adverse events (AEs) related to prior anticancer therapy.\n\nExclusion Criteria:\n\n1. Prior treatment with any agent targeting ROR1.\n2. History of Grade 4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies.\n3. Patient with primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Patients with solid tumors with CNS metastases are eligible if they do not need to receive local radiation treatment at the discretion of investigator or if radiation therapy for CNS metastases is completed ≥ 4 weeks prior to study treatment.\n4. Anticancer therapy or radiation \\\u003C 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment.\n5. Abuse on alcohol, cannabis-derived products, or other drugs.",{"count":306,"type":21},150,[24],"For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed.",[27,310],"Relapse\u002FRefractory Lymphoma",[312,313,314,315,316,317,27,310],"Phase I","Bispecific antibody","CD3","ROR1","EMB07","Dose escalation","2025-02-28",{"date":320,"type":32},"2025-03-03",{"date":322,"type":32},"2023-03-01",{"date":324,"type":21},"2026-03-31",{"name":326,"class":38},"EpimAb Biotherapeutics (Suzhou)Co., Ltd.",10,{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":337,"briefSummary":338,"conditions":339,"keywords":344,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":362},"100326192","phase-1-a-study-of-bispecific-antibody-mcla-158-in-patients-with-advanced-solid-tumors-100326192","NCT03526835","A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors","Phase 1\u002F2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.\n* A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe\u002Ffeasible).\n* Amenable for biopsy (if safe\u002Ffeasible).\n* Measurable disease as defined by RECIST version 1.1 by radiologic methods.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks, as per investigator.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).\n* Adequate organ function\n* Expansion cohorts: patients with locally advanced unresectable or metastatic disease for the following indications:\n\nSINGLE AGENT:\n\n* SECOND-\u002FTHIRD-LINE HNSCC PATIENTS (cohort closed to enrolment): patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy and platinum therapy as monotherapy or in combination with other agents and no previous exposure to EGFR inhibitors. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease should have disease progression within 6 months of the last dose of platinum containing therapy. Patients with no more than 2 prior lines of treatment in recurrent or metastatic disease.\n\n  * Human papilloma virus (HPV) status determined by p16 immunohistochemistry (IHC) or molecular HPV test for all oropharyngeal tumors should be reported when available.\n  * The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n* 3L+ mCRC (cohort open to enrolment) patients must have:\n\n  * No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, and no HER2 (ERBB2) amplification, as detected in plasma by ctDNA NGS central testing performed during screening.\n  * A microsatellite stable (MSS) tumor.\n\nCOMBINATION:\n\n* FIRST-LINE HNSCC (cohort closed to enrolment): patients eligible to receive pembrolizumab as first-line monotherapy with tumors expressing programmed cell death protein ligand 1 (PD-L1), combined positive score (CPS) ≥1, as determined by a Food and Drug Administration (FDA) approved test in the US, or by an approved equivalent test in other countries; patients should not have previous systemic therapy administered in the recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if ended ≥6 months prior to signing the ICF. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed.\n* mCRC (cohorts open to enrolment): Patients should have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Patients must be RAS\u002FRAF WT as determined using tumor tissue (primary or metastatic) by an appropriate tumor tissue based assay, to be confirmed by the sponsor, and must have an MSS tumor. Patients must be naive to prior anti-EGFR therapy.\n\n  * Cohort to be treated with petosemtamab and FOLFIRI: patients may have received up to 1 prior chemotherapy regimen for the metastatic setting, consisting of 1L fluoropyrimidine-oxaliplatin-based chemotherapy ± bevacizumab.\n  * Cohort to be treated with petosemtamab and FOLFOX: patients may have received up to 1 prior chemotherapy regimen in the metastatic setting consisting of 1L fluoropyrimidine-irinotecan-based chemotherapy ± bevacizumab.\n\nExclusion Criteria:\n\n* Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.\n* Known leptomeningeal involvement.\n* Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.\n* Any systemic anticancer therapy within 4 weeks or 5 half-lives whichever is shorter of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity ( e.g. mitomycin C,nitrosoureas), or anticancer immunotherapies, a washout period of 6 weeks is required.\n* Requirement for immunosuppressive medication (e.g. methotrexate, cyclophosphamide)\n* Major surgery or radiotherapy within 3 weeks of the first dose of study treatment. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible, irrespective of when it was received.\n* Persistent grade \\>1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v4.03 is allowed.\n* History of hypersensitivity reaction to any of the excipients of petosemtamab, human proteins or any non-IMP treatment required for this study.\n* Uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 150 mmHg and\u002For diastolic BP \\> 100 mmHg) with appropriate treatment or unstable angina.\n* History of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia).\n* History of myocardial infarction within 6 months of study entry.\n* History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease for 3 years.\n* Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy.\n* Patients with a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of ILD on baseline chest computerized tomography (CT) scan.\n* Current serious illness or medical conditions including, but not limited to uncontrolled active infection,clinically significant pulmonary, metabolic or psychiatric disorders.\n* Patients with known infectious diseases:\n\n  * Active hepatitis B infection ((hepatitis B surface antigen \\[HBsAg\\] positive) without receiving antiviral treatment.\n  * Positive test for hepatitis C ribonucleic acid (HCV) RNA).\n* Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-158.",{"count":336,"type":21},523,[24,71],"This is a Phase 1\u002F2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC.\n\nThe dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC).\n\nThe study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.",[27,340,341,342,163,165,343,149],"Colorectal Cancer","Gastric Cancer","Gastroesophageal-junction Cancer","Head and Neck Squamous Cell Carcinoma",[313,345,346,347,348,349,350,351,352],"First-in-human","MCLA-158","Antibodies","Bispecific","immunologic factors","Cytokines","EGFR","LGR5","2025-01-27",{"date":355,"type":32},"2025-01-29",{"date":357,"type":32},"2018-05-02",{"date":359,"type":21},"2027-11",{"name":361,"class":38},"Merus B.V.",45]