[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai JMT-Bio Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":564},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,46,70,92,115,138,159,179,200,220,241,266,287,309,330,350,372,392,412,433,454,476,498,522,543],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100582864","phase-1-a-study-of-jmt203-in-patients-with-cancer-cachexia-100582864",false,"NCT06868849","A Study of JMT203 in Patients With Cancer Cachexia","A Phase Ia\u002FII, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients With Cancer Cachexia","Inclusion Criteria:\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Voluntarily participate in the study and sign the informed consent form;\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Voluntarily participate in the study and sign the informed consent form;\n3. Malignant solid tumors confirmed histologically or cytologically, with ongoing or completed anti-tumor treatment, and no significant tumor progression within 28 days prior to the first drug administration，and the investigator estimates that the participant will not require a switch to another anticancer therapy due to disease progression during the first treatment cycle (21 days). For the Phase II portion:\n\n   * Cohort A (participants with colorectal cancer cachexia): Must meet the following treatment status: currently receiving or about to initiate investigator-selected second-line standard anticancer therapy, with no more than 5 cycles of second-line therapy, and not suitable for immune checkpoint inhibitors.;\n   * Cohort B (participants with pancreatic cancer cachexia): Must meet the following treatment status: currently receiving or about to initiate investigator-selected first-line standard anticancer therapy, with no more than 3 cycles of first-line therapy, and not suitable for targeted therapy.;\n   * Cohort C (participants with cachexia from other solid tumors): Currently receiving or have completed investigator-selected standard anticancer therapy, with no more than three prior lines of therapy.\n4. Diagnosed with cancer cachexia according to the criteria of the 2011 International Consensus on Cancer Cachexia: Definition and Classification, combined with characteristics of the Chinese population, i.e., presenting with one of the following within 6 months (previous weight data must be supported by written documentation approved by the sponsor): involuntary weight loss \\>5%, or weight loss \\>2% when Body Mass Index （BMI） \\\u003C18.5 kg\u002Fm²;\n5. Adequate organ function, meeting relevant laboratory test standards （without transfusion or hematopoietic growth factor support within 14 days prior to testing）:\n6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: ≤1;\n7. 7\\. Eastern Cooperative Oncology Group Performance Status （ECOG PS）score: ≤2;\n8. Estimated survival ≥4 months;\n9. Fertile eligible patients must use adequate contraceptive measures from the time of signing the informed consent form until 6 months after the last drug administration; female patients of childbearing age must have a negative serum pregnancy test within 7 days before the first drug administration.\n\nExclusion Criteria:\n\n1. Presence of reversible causes leading to decreased food intake;\n2. Patients with dysphagia or poor food digestion and absorption, including gastrointestinal obstruction, active inflammatory bowel disease, or short bowel syndrome;\n3. Patients with cachexia caused by clearly identified other causes, such as severe chronic obstructive pulmonary disease, uncontrolled thyroid disease, vital organ failure, or Acquired Immune Deficiency Syndrome （AIDS）;\n4. Patients receiving tube feeding or parenteral nutrition therapy during the screening period;\n5. Patients who have taken any prescription medications for appetite enhancement or improve weight loss within 28 days or 5 half-lives (whichever is shorter) before the first study drug administration, including but not limited to anamorelin, medroxyprogesterone acetate, dronabinol, medical marijuana, etc.;\n6. Initiation of systemic glucocorticoids (prednisone \\>10 mg\u002Fday or equivalent doses of other similar drugs) or other immunosuppressive therapies within 28 days before the first study drug administration, excluding pretreatment for antitumor therapy;\n7. Patients with a BMI exceeding 30 kg\u002Fm²;\n8. Patients who have undergone major surgery within 4 weeks before the first study drug administration and have not recovered, or are expected to undergo major surgery during the study;\n9. Patients who have received other clinical study medications within 4 weeks or 5 half-lives (whichever is shorter) before the first study drug administration;\n10. Patients with severe infections requiring intravenous antibiotics, antivirals, or antifungals during the screening period;\n11. Patients with difficult-to-control moderate to large amounts of serous cavity effusion, such as pericardial effusion or pleural\u002Fabdominal\u002Fpelvic effusion, within 14 days before the first study drug administration;\n12. Patients with a second primary active malignancy within 2 years before the first study drug administration, excluding locally curable tumors that have undergone radical treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, breast carcinoma in situ);\n13. Patients with active central nervous system metastases (brain metastases, carcinomatous meningitis, and spinal cord metastases), except for those with controlled lesions confirmed by imaging studies within 28 days before the first use of the investigational product;\n14. History of severe cardiovascular disease, including but not limited to:\n\n    1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, etc.;\n    2. Occurrence of acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of grade 3 or higher within 6 months before the first study drug administration;\n    3. New York Heart Association functional class ≥III or left ventricular ejection fraction (LVEF) \\\u003C50%;\n15. Patients with severe immune deficiency or a history of organ transplantation;\n16. Patients with recent (within the past year) or current depression or suicidal ideation\u002Ftendencies;\n17. Known allergy to JMT203 or its components;\n18. History of severe allergic reactions or uncontrollable allergic asthma;\n19. Patients deemed unsuitable for participation in this clinical study by the investigator for other reasons.","ALL","18 Years",{"count":20,"type":21},307,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","A Phase Ia\u002FII, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients with Cancer Cachexia",[28,29,30,31,32],"Non Small Cell Lung Cancer","Pancreatic Cancer","Cancer Cachexia","Colorectal Cancer Cachexia","Pancreatic Cancer Cachexia","RECRUITING","2026-05-19",{"date":36,"type":37},"2026-05-22","ACTUAL",{"date":39,"type":37},"2024-05-15",{"date":41,"type":21},"2029-05-15",{"name":43,"class":44},"Shanghai JMT-Bio Inc.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100634850","phase-2-a-study-of-jskn003-versus-trastuzumab-in-combination-with-pertuzumab-and-docetaxel-as-first-line-treatment-for-her2-positive-recurrent-or-metastatic-breast-cancer-100634850","NCT07545044","A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer","A Randomized, Controlled, Open-Label, Multicenter, Phase II Clinical Study Evaluating the Efficacy and Safety of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for Participants With HER2-Positive Recurrent or Metastatic Breast Cancer","Inclusion Criteria:\n\n* 1Voluntary participation in this study and signing of the informed consent form (ICF).\n* Age ≥ 18 years.\n* Histologically and\u002For cytologically confirmed recurrent or metastatic breast cancer.\n* HER2-positive tumor status confirmed by the central laboratory (Positive definition: IHC 3+, or IHC 2+ with positive ISH).\n* No prior systemic chemotherapy and\u002For HER2-targeted therapy for recurrent or metastatic disease. Participants who have received one prior endocrine therapy regimen are eligible. Participants who experienced recurrence more than 12 months after completing (neo)adjuvant HER2-targeted therapy may be considered for enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Presence of at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Adequate organ and bone marrow function (without transfusion or use of hematopoietic growth factors for correction within 14 days prior to testing):\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, Platelet count ≥ 100 × 10⁹\u002FL, Hemoglobin ≥ 90 g\u002FL.\n  2. Hepatic function: Total bilirubin (TBIL) ≤ 1.0 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases); alkaline phosphatase (ALP) ≤ 2.5 × ULN.\n  3. Renal function: Creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n  4. Coagulation function: International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. For participants receiving anticoagulant therapy, the investigator must deem both INR and APTT to be within a safe and effective therapeutic range.\n  5. Left ventricular ejection fraction (LVEF) \\> 50%.\n* Life expectancy ≥ 3 months.\n* For female participants of childbearing potential, a negative serum pregnancy test result must be obtained within 7 days prior to randomization. Participants of childbearing potential or those with partners of childbearing potential must agree to use reliable and effective methods of contraception during the study treatment period and for at least 7 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Contraindications to trastuzumab, pertuzumab, and docetaxel, or deemed by the investigator as unsuitable for treatment with JSKN003.\n* Prior treatment with antibody-drug conjugates containing a topoisomerase I inhibitor (e.g., DS-8201, SHR-A1811, TQB-2102, etc.).\n* Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE 6.0 (except for toxicities judged by the investigator to pose no safety risk, such as alopecia, peripheral neuropathy, or isolated laboratory abnormalities, which must have resolved to ≤ Grade 2).\n* During prior anti-HER2 therapy, left ventricular ejection fraction (LVEF) decreased to \\\u003C50%, symptomatic congestive heart failure occurred, or toxicity leading to permanent treatment discontinuation was experienced.\n* Known hypersensitivity and\u002For contraindications to corticosteroids (including but not limited to active peptic ulcer disease, severe hypertension, severe hypokalemia, glaucoma, etc.).\n* Use of strong CYP3A4 inhibitors within 14 days prior to randomization.\n* History of hypersensitivity to any component of the investigational drug(s) or any known excipient.\n* Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring corticosteroids or anticonvulsants to manage related symptoms. Participants are eligible if they have been clinically stable for \\>4 weeks after treatment for brain metastases without requiring corticosteroids or anticonvulsants and have recovered from acute toxicities of radiotherapy. Whole-brain radiotherapy or stereotactic radiosurgery must have been completed at least 2 weeks prior to study enrollment.\n* Active malignancy within 3 years prior to randomization, except for the breast cancer under investigation in this trial and any locally curable tumors that have undergone definitive treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, early-stage thyroid cancer, etc.).\n* Uncontrolled or significant cardiovascular or cerebrovascular diseases, including but not limited to:\n\n  1. New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction, or arrhythmia causing hemodynamic instability within 6 months prior to randomization;\n  2. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);\n  3. History of clinically significant QT interval prolongation, or QTcF (calculated using Fridericia's formula) \\>480 ms during screening;\n  4. Arterial\u002Fvenous thrombotic events within 6 months prior to randomization, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n  5. Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg).\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fnon-infectious pneumonitis requiring steroid treatment, current ILD\u002Fnon-infectious pneumonitis, or suspected ILD\u002Fnon-infectious pneumonitis that cannot be ruled out by imaging during screening.\n* Clinically significant pulmonary-specific comorbidities, including but not limited to any underlying pulmonary disease within 3 months prior to study enrollment, (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, moderate to large pleural effusion, etc.).\n* Prior pneumonectomy.\n* Any documented autoimmune, connective tissue, or inflammatory disease (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).\n* History of immunodeficiency, such as congenital immunodeficiency disease, organ transplantation, etc..\n* Uncontrolled active infection or disease, including but not limited to:\n\n  1. Active HBV or HCV infection. Participants who are HBsAg positive and\u002For HCV antibody positive during screening must undergo HBV DNA and\u002For HCV RNA testing. Only participants with HBV DNA below the upper limit of normal and\u002For negative HCV RNA are eligible;\n  2. HIV infection or history of AIDS;\n  3. Known active tuberculosis;\n  4. Active syphilis. Participants with positive TP-Ab during screening must undergo TRUST or RPR testing; participants positive for both are excluded;\n  5. Other active infections or systemic use of anti-infective drugs for more than 1 week continuously within 28 days prior to randomization.\n* History of partial or complete intestinal obstruction, inflammatory bowel disease, chronic diarrhea, or gastrointestinal bleeding within 6 months prior to randomization.\n* Concurrent participation in another clinical study (except for non-interventional studies or the follow-up phase of an interventional study) or less than 4 weeks from the end of the previous clinical study (last dose) at the time of randomization.\n* Anti-tumor therapy including radiotherapy, targeted therapy, immunotherapy, and other investigational drugs within 28 days prior to randomization, or use of traditional Chinese medicine with anti-tumor indications within 14 days prior to randomization.\n* Uncontrolled serous cavity effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring frequent drainage or medical intervention within 14 days prior to randomization, or requiring additional intervention within 2 weeks post-intervention (excluding cytological examination of effusion).\n* Major surgical procedures (e.g., abdominal, thoracic surgery; excluding minor procedures such as diagnostic puncture, infusion port placement, or biliary stent placement) within 28 days prior to randomization, or anticipated need for major surgery during the study period.\n* Women who are breastfeeding.\n* Any other condition that may interfere with the participant's ability to undergo study procedures, is not in the participant's best interest to participate, or may affect study outcomes: e.g., history of psychiatric disorders, drug or substance abuse, or any other clinically significant disease or condition.",{"count":54,"type":21},60,[25],"This study is a randomized, controlled, open-label, multicenter, phase II superiority clinical trial. The planned study population consists of participants with HER2-positive recurrent or metastatic breast cancer who have not previously received systemic therapy for advanced disease (participants who have undergone one prior endocrine treatment regimen are eligible for enrollment). The study aims to compare the efficacy and safety of JSKN003 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for participants with HER2-positive recurrent or metastatic breast cancer.",[58],"HER2-positive Recurrent or Metastatic Breast Cancer",[60],"breast cancer, HER2-positive, first-line treatment","NOT_YET_RECRUITING","2026-04-15",{"date":64,"type":37},"2026-04-22",{"date":66,"type":21},"2026-05-30",{"date":68,"type":21},"2027-05-30",{"name":43,"class":44},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":45},"100626886","phase-3-a-phase-iii-study-of-kn026-in-combination-with-hb1801-as-adjuvant-therapy-for-resectable-her2-positive-breast-cancer-100626886","NCT07441460","A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer","A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of KN026 Combined With HB1801 and Chemotherapy Versus Trastuzumab Combined With Pertuzumab and Chemotherapy as Adjuvant Therapy in Resectable HER2-positive Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form.\n2. Age ≥ 18 years.\n3. ECOG performance status score of 0 or 1.\n4. Histologically or cytologically confirmed invasive breast cancer.\n5. Must have undergone prior radical mastectomy or breast-conserving surgery for breast cancer.\n6. Pathologically confirmed positive regional lymph nodes.\n7. Tumor tissue confirmed as HER2-positive by the local laboratory.\n8. Adequate organ and bone marrow function:\n\n   1. Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL\n   2. Platelet count ≥ 100 × 10⁹\u002FL\n   3. Hemoglobin ≥ 90 g\u002FL\n   4. Liver function: Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for participants with Gilbert's syndrome); ALT and AST ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN\n   5. Coagulation function: INR ≤ 1.5 × ULN and aPTT ≤ 1.5 × ULN\n   6. Renal function: Creatinine clearance ≥ 50 mL\u002Fmin\n   7. LVEF ≥ 55%\n9. Female participants of childbearing potential must have a negative blood pregnancy test result within 7 days prior to randomization, and agree to use reliable and effective contraception during the study treatment period and for 7 months after the last dose of study treatment. Male participants with female partners of childbearing potential must agree to use reliable and effective contraception during the study treatment period and for 7 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. History of any prior ipsilateral and\u002For contralateral invasive breast cancer.\n2. History of other malignancy within 5 years prior to randomization, except for the breast cancer under study and locally curable malignancies treated with curative intent.\n3. Prior systemic chemotherapy, endocrine therapy, anti-HER2 targeted therapy, or local radiotherapy for breast cancer.\n4. Use of strong CYP3A4 inhibitors within 14 days prior to randomization or planned use during the combination chemotherapy period.\n5. Known contraindication to any study drug or history of hypersensitivity to any component or known excipient of the study drugs.\n6. Significant cardiovascular disease history, including: prior coronary artery bypass graft or coronary stenting; myocardial infarction or cerebrovascular accident within 6 months prior to randomization; history of congestive heart failure\u002Fsystolic dysfunction (LVEF \\\u003C 50%) or unstable angina; history of clinically significant prolonged QT interval or QTcF (Fridericia) \\> 450 ms at screening; uncontrolled severe hypertension (systolic BP \\> 180 mmHg and\u002For diastolic BP \\> 100 mmHg); high-risk arrhythmias \\[e.g., atrial tachycardia with resting heart rate ≥ 100 bpm, significant ventricular arrhythmia (ventricular tachycardia), or high-grade atrioventricular block (Mobitz type II second-degree or third-degree AV block)\\].\n7. Severe chronic or active infection requiring intravenous anti-infective therapy within 14 days prior to randomization.\n8. Participation in another interventional clinical trial within 4 weeks prior to randomization.\n9. Pregnant or lactating women.\n10. Any other condition that may interfere with the participant's ability to comply with study procedures, may not be in the participant's best interest to participate, or may affect study results (e.g., history of neurological or psychiatric disorders, alcohol or drug abuse, or any other clinically significant disease or condition).",{"count":78,"type":21},1800,[80],"PHASE3","This is a randomized, controlled, open-label, multicenter, Phase Ⅲ clinical study designed to compare the efficacy and safety of KN026 combined with HB1801 and chemotherapy versus trastuzumab combined with pertuzumab and chemotherapy as adjuvant therapy in participants with HER2-positive breast cancer.",[83],"Resectable HER2-positive Breast Cancer","2026-04-02",{"date":86,"type":37},"2026-04-08",{"date":88,"type":37},"2026-03-06",{"date":90,"type":21},"2035-08-07",{"name":43,"class":44},{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100629282","phase-1-sys6090-combination-therapy-in-advanced-lung-cancer-100629282","NCT07472647","SYS6090 Combination Therapy in Advanced Lung Cancer","A Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily signed written informed consent.\n2. Age 18 to 75 years at the time of informed consent, with no restriction on sex.\n3. Histologically or cytologically confirmed unresectable locally advanced (stage IIIB\u002FIIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) according to the AJCC\u002FUICC Cancer Staging System, 8th edition, or extensive-stage small cell lung cancer (SCLC), not amenable to curative surgical resection or definitive chemoradiotherapy.\n4. At least one measurable lesion according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Estimated life expectancy of at least 3 months.\n7. Has protocol-defined adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Use of systemic corticosteroids or other immunosuppressive therapies within 14 days prior to the first dose of study treatment, except for physiologic replacement doses or permitted local, inhaled, or prophylactic use.\n2. Unresolved \\> Grade 1 toxicities related to prior anticancer therapy (except for toxicities judged by the investigator to pose no safety risk).\n3. For Cohorts 5A and 5B: prior permanent discontinuation of EGFR-targeted therapy due to dermatologic toxicity, or presence of dermatologic diseases requiring systemic treatment.\n4. Known active central nervous system metastases or leptomeningeal metastases, except for stable and adequately treated brain metastases without the need for ongoing corticosteroids or antiepileptic therapy.\n5. History of interstitial lung disease or non-infectious pneumonitis requiring corticosteroid treatment; current ILD or non-infectious pneumonitis; or inability to exclude these conditions at screening.\n6. History of severe cardiovascular or cerebrovascular disease.\n7. Active or recurrent autoimmune disease requiring systemic treatment, except for clinically stable or well-controlled conditions as specified in the protocol.\n8. Prior immunotherapy associated with severe immune-related adverse events (≥ Grade 3) or immune-related myocarditis (≥ Grade 2), excluding stable immune-related endocrine disorders.\n9. Clinically significant bleeding events (≥ Grade 2 according to NCI-CTCAE v6.0) within 4 weeks prior to the first dose of study treatment.\n10. Arterial or venous thromboembolic events within 6 months prior to the first dose of study treatment, unless judged by the investigator to be clinically stable and low risk.\n11. Presence of ascites or pleural effusion requiring drainage within 14 days prior to the first dose.\n12. Known hypersensitivity to any component of the study treatment, history of severe hypersensitivity or infusion-related reactions to protein-based therapies, or poorly controlled asthma.\n13. Untreated spinal cord compression.\n14. History of other malignancies within 2 years prior to enrollment or concurrent active malignancy, except for cured localized tumors. -","75 Years",{"count":101,"type":21},596,[24,25],"This is an open-label, multi-cohort, multicenter Phase Ib\u002FII clinical study designed to evaluate the safety, tolerability, and efficacy of SYS6090 injection in combination with chemotherapy or chemotherapy and bevacizumab or SYS6010 (an EGFR ADC) in participants with advanced lung cancer.",[105,106],"Non-Small Cell Lung Cancer","Small Cell Lung Cancer","2026-03-12",{"date":109,"type":37},"2026-03-16",{"date":111,"type":21},"2026-02-28",{"date":113,"type":21},"2030-02-28",{"name":43,"class":44},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":17,"minAge":18,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":45},"100625212","phase-1-evaluate-the-safety-tolerability-pk-and-pd-of-jmt206-injection-in-healthy-participants-100625212","NCT07419698","Evaluate the Safety, Tolerability, PK, and PD of JMT206 Injection in Healthy Participants","A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMT206 Injection in Healthy Subjects","Inclusion Criteria:\n\n1. Aged 18 to 60 years (inclusive) at screening, male or female.\n2. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening, with a body mass index (BMI) ranging from 19.0 to 28.0 kg\u002Fm\\^2 (inclusive).\n3. Body weight change \\\u003C 5% within 3 months prior to screening, and consistent diet and exercise habits maintained from screening until prior to dosing (based on participants's statement). Calculation formula: (Body weight at 12 weeks prior to screening - Body weight at screening) \u002F Body weight at screening \\* 100%.\n4. Results of examinations such as vital signs, physical examination, 12-lead electrocardiogram (ECG), posteroanterior chest X-ray, B-ultrasound (abdomen, urinary system, gynecological (female only)), and clinical laboratory tests (including but not limited to complete blood count, urinalysis, blood biochemistry, coagulation function, serum virology, thyroid function, tumor marker tests, etc.) are within normal ranges or assessed by the investigator as abnormal but not clinically significant.\n5. Both the participant and their partner agree to use a contraceptive method with a ≤1% annual failure rate or maintain abstinence from signing the informed consent form until 6 months after the last dose. Male participants have no plan to donate sperm from signing the informed consent until 6 months after the last dose; female participants have no plan to donate ova from signing the informed consent until 6 months after the last dose.\n6. Able to read, understand, and provide written informed consent for the study-related information. Have a full understanding of the trial content, procedures, and potential adverse reactions. Voluntarily sign the informed consent form prior to the trial and ensure personal participation in all study procedures.\n\nExclusion Criteria:\n\n1. Participants with a history of hypersensitivity or known\u002Fsuspected allergy to JMT206 or any component of the investigational product.\n2. Participants with a history of risk factors for Torsades de pointes (TdP) (e.g., heart failure\u002Fcardiomyopathy or family history of long QT syndrome), uncorrected hypokalemia or hypomagnesemia (one retest allowed per investigator's judgment), or currently taking concomitant medications known to prolong the QT\u002FQTc interval.\n3. Participants with a current clinically significant illness, or history of chronic or severe diseases. This includes, but is not limited to, diseases of the circulatory, lymphatic, respiratory, endocrine, urinary, digestive, nervous or psychiatric systems, infections, malignancies, severe trauma, or any other condition that the investigator considers grounds for exclusion or may interfere with the interpretation of the study results.\n4. Participants with known concomitant conditions that affect skeletal muscle protein, or use of any form of skeletal muscle anabolic drugs or supplements within 3 months prior to screening.\n5. Participants with a history of gastrointestinal surgery resulting in malabsorption, or long-term use of drugs that directly affect gastrointestinal motility. Examples include: prior bariatric surgery or procedures (e.g., gastric banding); use of medications or products deemed by the investigator to cause weight changes and affect weight assessment within 3 months prior to dosing; or intention to use weight-loss medications during the study period.\n6. Use of any prescription drugs, over-the-counter medications, or Chinese herbal medicines within 4 weeks prior to screening.\n7. Average alcohol consumption exceeding 14 units per week within 3 months prior to screening (1 unit = 285 mL of beer, 25 mL of spirits, or 150 mL of wine), or consumption of any alcohol-containing products within 48 hours prior to investigational product administration, or a positive alcohol breath test, or inability to abstain from alcohol during the trial.\n8. Smoking ≥5 cigarettes per day within 6 months prior to screening, or smoking within 48 hours prior to investigational product administration, or inability to discontinue use of any tobacco products during the trial.\n9. Habitual consumption within 3 months prior to screening, or ingestion within 72 hours prior to investigational product administration, of pitaya (dragon fruit), mango, pomelo, carambola (star fruit), or foods\u002Fbeverages prepared from them; or excessive intake of foods\u002Fbeverages containing xanthine or caffeine, or other items known to affect drug absorption, distribution, metabolism, or excretion. Examples include: coffee (\\>1100 mL\u002Fday), tea (\\>2200 mL\u002Fday), cola (\\>2200 mL\u002Fday), energy drinks (\\>1100 mL\u002Fday), chocolate (\\>510 g\u002Fday).\n10. History of drug abuse within 6 months prior to screening, or a positive drug abuse screening test.\n11. Transfusion, blood loss, or blood donation exceeding 400 mL within 3 months prior to dosing (excluding menstrual blood loss in females), and\u002For platelet donation within 2 weeks prior to dosing.\n12. History of needle or blood phobia (vasovagal syncope related to needles or blood), difficult blood sampling, or intolerance to venipuncture.\n13. Participants with specific dietary requirements who cannot comply with the standardized diet and schedule.\n14. Female participants who are pregnant, lactating, or have a positive pregnancy test at screening.\n15. Participation in any drug or medical device clinical trial within 3 months prior to screening, or planning to participate in another clinical trial during the study period.\n16. Any other condition or circumstance that, in the investigator's judgment, renders the participant unsuitable for participation in the study",true,"60 Years",{"count":125,"type":21},44,[24],"A This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical trial. It aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single administration of JMT206 Injection in healthy participants.",[129],"Healthy Participants","2026-02-12",{"date":132,"type":37},"2026-02-19",{"date":134,"type":37},"2026-01-26",{"date":136,"type":21},"2026-11-01",{"name":43,"class":44},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":45},"100583540","phase-1-first-in-human-investigation-of-jmt108-injection-in-participants-with-advanced-malignant-tumors-100583540","NCT06877650","First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors.","Inclusion Criteria:\n\n1. Fully informed of the study, with good compliance and willing to provide written informed consent.\n2. Male or female participants aged ≥18 years (at the time of obtaining informed consent).\n3. Participants with histologically or cytologically confirmed advanced malignant tumors who are unresponsive or intolerant to all standard of care, or have no standard of care available. For locally advanced (stage IIIB\u002FIIIC) or metastatic (stage IV) NSCLC without sensitive gene mutations, participants who have not received systemic treatment in the advanced stage and are unwilling to accept the current standard treatment can also be enrolled in the cohort expansion phase.\n4. Participants with at least one evaluable tumor lesion in the Phase 1a dose-escalation phase; and at least one measurable lesion in the Phase 1a dose-expansion phase and Phase 1b (tumor lesions in the past radiation fields or that underwent locoregional therapy are generally not considered measurable lesions unless the lesion shows definite progression or persists three months after radiotherapy) according to RECIST v1.1.\n5. Stage I: ECOG performance score ≤ 2. Stage II: ECOG performance score 0-1\n6. Expected survival ≥ 3 months.\n7. Adequate organ function status:\n\nHematology: PLT ≥ 100×109\u002FL; Hb ≥ 90 g\u002FL; ANC) ≥ 1.5×109\u002FL (No blood transfusion, platelet transfusion, or hematopoietic stimulating factor therapy within 14 days prior to hematology test during the screening period); Liver function: AST and ALT ≤3×ULN (≤5×ULN if there is liver involvement by the tumor); TBIL ≤1.5×ULN; Renal function: Ccr \\> 50 ml\u002Fmin (calculated by the Cockcroft-Gault formula); Coagulation function: APTT ≤ 1.5×ULN; INR ≤ 1.5×ULN; For participants on full - dose oral anticoagulant therapy, maintain a stable dosage for at least 14 days. If on warfarin, INR ≤ 3.0 with no active hemorrhage (e.g., no bleeding 14 days before the first dose of the investigational drug). Low molecular weight heparin use is permitted.\n\nAlbumin: ≥30 g\u002FL (≥3.0 g\u002FdL).\n\nExclusion Criteria:\n\n1. Any other unapproved investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug (C1D1).\n2. Chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor therapies within 4 weeks prior to the first dose of the investigational drug, except in the following situations:\n\n   Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug; Use of oral fluoropyrimidines and small-molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of the investigational drug; Use of herbal medicine\u002Fproducts with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.\n3. Major surgery (excluding biopsy) or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug, or plan to do major surgery during the study period.\n4. Systemic corticosteroids or other immunosuppression therapy within 14 days prior to the first dose of the investigational drug. Except for the following situations: use of physiological replacement doses of hydrocortisone or other equivalent doses of hormones (i.e., prednisone ≤10 mg\u002Fday or other equivalent doses of hormones); use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroid therapy; use of short-course glucocorticoids for prophylaxis (e.g., prevention of contrast allergy).\n5. Live vaccines within 4 weeks prior to the first dose of investigational drug. Note: Seasonal influenza vaccines are inactivated vaccines in a broad sense and are allowed. Intranasal influenza vaccines are live vaccines and are not permitted.\n6. History of hematopoietic stem cell transplant or organ transplant.\n7. AEs from prior therapy which have not recovered to Grade ≤1 or baseline as per NCI CTCAE v5.0 (excluding toxicities evaluated by the investigator to have no safety risk, such as alopecia, Grade 2 peripheral neurotoxicity, hypothyroidism stabilized with hormone replacement therapy, etc.).\n8. Active central nervous system metastases and\u002For leptomeningeal metastases. Participants with brain metastases who have confirmed progression-free status by imaging examinations for at least 4 weeks after treatment and who have not required hormonal or antiepileptic therapy for at least 2 weeks may be considered for enrollment.\n9. History of interstitial lung disease or pneumonitis.\n10. History of serious cardiovascular and cerebrovascular diseases.\n11. Active or recurrent autoimmune diseases (such as systemic lupus erythematosus, arthritis, vasculitis, etc.).\n12. History of Grade ≥3 immune-related AE or Grade ≥2 immune-related myocarditis considered related to prior immune modulatory therapytherapy.\n13. Hemorrhage of Grade ≥2 as per NCI CTCAE v5.0 within 4 weeks prior to the first dose of the investigational drug.\n\n    \\-",{"count":146,"type":21},436,[24,25],"This study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108 injection, and to determine the RP2D\u002Fschedule for subsequent studies.",[150],"Advanced Malignant Tumors","2026-01-27",{"date":153,"type":37},"2026-01-29",{"date":155,"type":37},"2025-04-11",{"date":157,"type":21},"2029-03-30",{"name":43,"class":44},{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100622496","phase-3-jskn003-versus-physician-choiced-treatment-in-patients-with-her2-positive-and-advanced-colorectal-cancer-who-had-failed-to-respond-to-oxaliplatin-5-fu-and-irinotecan-100622496","NCT07384377","JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan","A Phase III Trial to Evaluate the Efficacy and Safety of JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan","Inclusion Criteria:\n\n* Age≥18 years old.\n* Unresectable locally advanced or distant metastatic BRAFV600E wild-type colorectal cancer diagnosed histologically or cytologically.\n* After treatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR\u002FMSI-H subjects also need anti-PD-1\u002FPD-L1 antibody treatment failure).\n* HER2-positive (defined as IHC3+ or IHC 2+\u002FFISH +).\n* According to the response evaluation criteria for solid tumors (RECIST 1.1), having at least one assessable lesion, assessable lesions should not have received local treatment such as radiotherapy (lesions located within the previously treated area may also be targeted if progression is confirmed).\n* ECOG PS of 0-1.\n* Expected survival ≥ 3 months.\n* Participants with adequate organ functions.\n* Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 7 months after the last dose. Female participants of childbearing age must have a negative blood pregnancy test within 7 days before the first dose or randomization.\n* Voluntarily agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Participants who have previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors.\n* Participants with brain metastasis or spinal cord compression at screening.\n* Previous antineoplastic therapy toxicities did not revert to a CTCAE v5.0 grade rating of ≤1.\n* There are obvious clinical manifestations of gastrointestinal abnormalities, including but not limited to: having experienced intestinal obstruction or symptoms and signs of intestinal obstruction within 3 months prior to administration; having had gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 3 months prior to administration; having experienced gastrointestinal bleeding of CTCAE grade ≥ 3 within 3 months prior to administration, or having had gastrointestinal bleeding within the previous 1 month.\n* Participants who have undergone major surgery or had invasive intervention within 28 days before the randomization. Or those who plan to undergo systematic or local tumor resection during the trial.\n* Participate in another clinical trial, unless it is an observational (non-intervention) clinical trial or is in the follow-up period of an intervention trial.\n* Participants who have used any Chinese herbal medicine or Chinese patent medicine approved by the national drug regulatory authority for its anti-cancer properties within the previous 14 days (regardless of the type of cancer); have received palliative radiotherapy within the 14 days prior to randomization; have received systemic anti-tumor treatment within 4 weeks or 5 half-life (whichever is shorter but at least 2 weeks) prior to randomization.\n* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.\n* Participants who have active bacterial, fungal or viral infections 14 days before the randomization.\n* Within the 14 days before the randomization, participants who had a situation where there was an uncontrollable need for frequent drainage or medical intervention in the serous cavity effusion.\n* Participant with positive hepatitis B surface antigen (HBsAg) and HBV-DNA is higher than 500 IU\u002FmL (or 2500 copies\u002Fml) (whichever is lower) ; Participants with positive for hepatitis C (HCV) antibody and HCV-RNA is higher than 1000 copies\u002Fml or UNL (whichever is lower).\n* Has activity or a history of interstitial lung disease at any stage and\u002For pulmonary function injury, a history of interstitial pneumonia requiring hormone therapy, or the imaging cannot rule out suspected interstitial lung disease\u002Fpneumonia at screening.\n* Has a history of severe cardiovascular disease.\n* History of any other malignant tumors within 5 years.\n* Pregnant or breastfeeding women.\n* Otherwise considered inappropriate for the study by the investigator.",{"count":167,"type":21},123,[80],"The study is being conducted to evaluate the efficacy and safety of JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan subjects.",[171],"HER2-positive Colorectal Cancer",{"date":173,"type":37},"2026-02-03",{"date":175,"type":21},"2026-02-06",{"date":177,"type":21},"2028-06-15",{"name":43,"class":44},{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":4},"100618508","phase-2-a-study-of-kn026-based-combination-therapy-in-her2-positive-gastric-cancer-100618508","NCT07332533","A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer","A Phase II\u002FIII Study of KN026 Combined Chemotherapy With or Without Enlonstobart as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Gastric Cancer.","Inclusion Criteria:\n\nAge≥18 years old.\n\n* Histologically or cytologically confirmed diagnosis of gastric cancer.\n* Participants unresectable locally advanced or metastatic gastric cancer who had not received systemic treatment (participants who had progressed 6 months after prior neoadjuvant\u002Fadjuvant therapy could be enrolled).\n* Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive) and PD-L1 status (participants of phase III should be confirmed by the pathology department of participating study center).\n* Phase II: Presence of at least 1 measurable lesion per RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Phase III:Presence of at least 1 evaluable lesion per RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* ECOG PS of 0 - 1.\n* Expected survival ≥ 3 months.\n* Participants with adequate organ functions.\n* Female and male participants of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 7 months after the last dose. Female participants of childbearing age must have a negative blood pregnancy test within 7 days before randomization.\n* Voluntarily agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Has received anti-tumor treatment such as systemic chemotherapy or other trial interventions within 28 days, or immunotherapy (e.g. interleukin, interferon, thymospipeptide, etc.), hormone therapy or targeted therapy within 14 days or 5 half-life (whichever is shorter) before randomization.\n* Participants with brain metastasis or spinal cord compression at screening (except for completed local treatment and discontinued glucocorticoids for at least 4 weeks before randomization , and stable central nervous system imaging and brain metastasis symptoms for at least 4 weeks).\n* Participants with PD-L1 CPS ≥1, who are receiving long-term immunotherapy (e.g., cyclosporine) or require daily systemic steroid therapy (e.g., \\>20 mg prednisone or equivalent), except those who treated with local glucocorticoids using nasal spray, inhalation, or other pathways.\n* Participants with PD-L1CPS ≥1, who have an active autoimmune disease or have a history of autoimmune disease 2 years before randomization and still require systemic treatment. However, participant with the following diseases is allowed to enroll: well-controlled type I diabetes, well-controlled hypothyroidism that requires hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or participant who is expected to not recur without external triggers.\n* Participate in another clinical trial, unless it is an observational (non-intervention) clinical trial or is in the follow-up period of an intervention trial.\n* Participants who have undergone major surgery or had invasive intervention within 28 days before randomization. Or those who plan to undergo systematic or local tumor resection during the trial .\n* Any Chinese patent medicine with anti-cancer activity approved by the National Drug Administration (regardless of cancer type) has been used within 14 days before randomization.\n* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.\n* Active bacterial, fungal or viral infection before randomization. Participant who has recieved preventive infection treatment but has no clinical manifestations before randomization could be considered to enroll.\n* Has a history of immunodeficiency, including HIV-positive.\n* Active hepatitis B or C infection. Participant with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) need to test Hepatitis B virus DeoxyriboNucleic Acid (HBV-DNA), and HBV-DNA is higher than 500 IU\u002FmL (or 2500 copies\u002Fml) ; Participants with positive for hepatitis C (HCV) antibody and whose Hepatitis C virus Ribonucleic Acid (HCV-RNA) is higher than 1000 copies\u002Fml or UNL (whichever is lower).\n* Has a history of tuberculosis treatment within 2 years before randomization.\n* Has activity or a history of interstitial lung disease at any stage and\u002For pulmonary function injury, a history of interstitial pneumonia requiring hormone therapy, or the imaging cannot rule out suspected interstitial lung disease\u002Fpneumonia at screening.\n* Known to have low activity or lack of dihydropyrimidine dehydrogenase (DPD).\n* Participants with peripheral neuropathy of grade \\> 1.\n* Participants with clinically significant gastrointestinal diseases including but not limited to severe liver diseases, ulcerative colitis, Crohn's disease and other gastrointestinal diseases 28 days before randomization; Unable to swallow orally, or there are conditions that have been judged by researchers to seriously affect gastrointestinal absorption (such as malabsorption syndrome, etc.).\n* Has a history of severe cardiovascular disease.\n* History of any other malignant tumors within 5 years before randomization.\n* pleural effussion, peritoneal dropsy or pericardial effusion requiring drainage within 2 weeks before randomization.\n* Live vaccination within 28 days before randomization. Note: Seasonal influenza vaccine is a broadly inactivated vaccine and is allowed to be used;\n* Breastfeeding women.\n* Otherwise considered inappropriate for the study by the investigator.",{"count":187,"type":21},490,[25,80],"This study is designed to compare the efficacy and safety of KN026 combined chemotherapy with or without Enlonstobart versus Trastuzumab combined chemotherapy with or without Pembrolizumab as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer.",[191],"HER2-positive Gastric Cancer","2026-01-08",{"date":194,"type":37},"2026-01-12",{"date":196,"type":21},"2025-12-30",{"date":198,"type":21},"2032-12-31",{"name":43,"class":44},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":219,"locationsCount":45},"100614533","phase-1-phase-iii-clinical-study-of-jmt108-injection-for-the-treatment-of-advanced-malignant-melanoma-100614533","NCT07280832","Phase I\u002FII Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma","Open-Label, Multicenter Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT108 Injection in Participants With Unresectable or Metastatic Melanoma","Inclusion Criteria:\n\n1. Age≥18 years old.\n2. Histologically or cytologically confirmed unresectable locally advanced or metastatic melanoma.\n3. Participants with unresectable locally advanced or metastatic melanoma who have failed prior standard treatment or have no available standard treatment will be enrolled in Phase I and Phase IIa; those who have received or not received prior standard treatment will be enrolled in Phase IIb.\n4. According to the response evaluation criteria for solid tumors (RECIST 1.1), having at least one measurable lesion.\n5. ECOG PS of 0-1.\n6. Expected survival ≥ 3 months.\n7. Participants with adequate organ functions.\n8. Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 6 months after the last dose. Female participants of childbearing age must have a negative blood pregnancy test within 7 days before the first dose or randomization.\n9. Voluntarily agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or other unapproved clinical trial drugs or treatments within 4 weeks prior to the first administration of the study drug.\n2. Prior use of IL-2\u002FIL-15 cytokine therapy.\n3. Received major organ surgery (excluding needle biopsy) or experienced severe trauma within 4 weeks prior to the first administration of the study drug, or requires elective surgery during the study period.\n4. Received systemic glucocorticoids or other immunosuppressive therapy within 14 days prior to the first use of the study drug. Exceptions include the following situations: receiving physiological replacement doses of hydrocortisone or other equivalent doses of hormonal therapy (i.e., prednisone ≤ 10 mg\u002Fday or other equivalent doses of hormones); receiving topical, ophthalmic, intra-articular, intranasal, and inhaled glucocorticoid therapy; receiving short-course glucocorticoids for preventive treatment (e.g., prevention of contrast agent allergy).\n5. Known active central nervous system (CNS) metastases and\u002For leptomeningeal metastases. Patients with stable brain metastases who do not require local treatment for brain metastases are eligible for inclusion.\n6. Patients with active infections requiring intravenous anti-infective therapy within 14 days prior to the first administration.\n7. Has a history of severe cardiovascular and cerebrovascular diseases.\n8. Has active or recurrent autoimmune diseases.\n9. Has a known history of receiving immunotherapy with the occurrence of grade ≥3 immune-related adverse events (irAEs) (excluding immune-related endocrine abnormalities that have been stabilized) or grade ≥2 immune-related myocarditis.\n10. Has a history of arterial or venous thrombosis within 6 months prior to the first administration.\n11. Has a history of serous effusions such as ascites or pleural effusion requiring drainage within 14 days prior to the first administration.\n12. Has a history of other malignant tumors within 5 years prior to the first administration or concurrent other malignant tumors.",{"count":208,"type":21},188,[24,25],"This is an open-label, multicenter Phase I\u002FII clinical study conducted in participants with unresectable locally advanced or metastatic melanoma, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of JMT108 Injection in this population. The study consists of Phase I and Phase II (including Phase IIa and Phase IIb), where Phase I is the dose-escalation stage, Phase IIa is the dose-expansion stage, and Phase IIb is the cohort-expansion stage.",[212],"Unresectable Locally Advanced or Metastatic Melanoma","2026-01-06",{"date":215,"type":37},"2026-01-07",{"date":217,"type":37},"2025-12-17",{"date":68,"type":21},{"name":43,"class":44},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":45},"100603768","phase-1-a-phase-1b2a-study-of-jmt202-injection-in-participants-with-hypertriglyceridemia-100603768","NCT07140809","a Phase 1b\u002F2a Study of JMT202 Injection in Participants With Hypertriglyceridemia","a Multiple-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Escalation Phase Ib\u002FⅡa Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetic Characteristics of JMT202 Injection in Chinese Participants With Hypertriglyceridemia","phase Ib\u002FⅡa st","Inclusion Criteria:\n\n* Age ≥18 and ≤75 years old (at the time of signing the informed consent form), gender not limited.\n* The weight is ≥45.0 kg (for females) or ≥50.0 kg (for males), and the body mass index is between 24.0 and 40.0 kg\u002Fm ² (including the cut-off value). The body mass index is calculated as \\[BMI= weight (kg)\u002Fheight 2 (m ²)\\].\n* TG\\>300 mg\u002FdL (3.39 mmol\u002FL) within 28 days before screening; During the screening period, the TG of the participants met the following requirements: ① Two TG values within the screening period, with an interval of ≥7 days, and both TG values met the requirement of 300 mg\u002FdL≤TG\\\u003C1000 mg\u002FdL (11.30 mmol\u002FL); ② The last TG test was less than 7 days before administration (D1).\n* Participants need to meet:\n\n  1. Receive stable lipid-lowering treatment for ≥28 days before screening;\n  2. Accept lipid-lowering medications before screening of less than 28 days, but random stable lipid-lowering therapy, 28 days or more before test TG and D - 1 \\> 300 mg\u002FdL (the tendency for 3.39 L) screening of unused lipid-lowering within 28 days before,\n  3. During the screening period, at least one screening should be conducted at a concentration of 300 mg\u002FdL (3.39 mmol\u002FL) ≤TG\\\u003C500 mg\u002FdL (5.65 mmol\u002FL).\n  4. Screening unused lipid-lowering, within 28 days before screening period two TG 500 mg\u002FdL or higher tendency (5.65 L), need before random stable lipid-lowering therapy, 28 days or TG test and D - 1 \\> 300 mg\u002FdL (the tendency for 3.39 L).Lipid-lowering treatment: niacin ≥375 mg\u002F day, prescription fish oil, fibrates, statins, ezetimibe, etc. PCSK9 inhibitors need to be stable for 6 months before screening.\n* Some participants (at least 4 cases per dose group) had MRI-PDFF≥8%;\n* From 28 days before screening to the entire trial period, participants should maintain their original diet, exercise and lifestyle habits as much as possible, and avoid alcohol and strenuous exercise within 48 hours before each visit.\n* Participants and their partners agree that they must use effective and reliable contraceptive methods from the signing of the informed consent form until 6 months after the end of the trial (female participants are not allowed to use hormonal contraceptives from 14 days before screening until the entire trial period) to prevent pregnancy in either female or male participants' partners. Male participants had no sperm donation plans from signing the informed consent form to 6 months after the end of the trial, and female participants had no egg donation plans from signing the informed consent form to 6 months after the end of the trial.\n* Participants voluntarily join the clinical trial and sign the informed consent form, and have the ability to communicate normally with the researchers while abiding by the trial requirements.\n\nExclusion Criteria:\n\n* Weight changed by ≥5% within the 3 months prior to randomization, or who planned to lose weight throughout the trial period;\n* Screening products targeting the FGF21 target that have been used within the previous year, such as BIO89-100, DR10624, etc.\n* Participants with Type 1 diabetes No stable hypoglycemic drug treatment within 3 months prior to screening or randomization (the use of glucagon-like peptide-1 receptor agonists, single-target or multi-target drugs, thiazolidinediones or insulin was prohibited from 3 months prior to screening until the entire trial period) Other oral or injectable drugs should have been stably treated for ≥3 months before screening and the dose should be maintained stably throughout the trial period, or the glycated hemoglobin should be ≥9.5% during the screening period.\n* Participants who are known or suspected of having familial hyperchylomicemia, lipoprotein lipase injury or deficiency (Fredrickson type 1), apolipoprotein C-II deficiency or familial lipoprotein dyslipidemia (Fredrickson type 3);\n* Participants with a history of gallbladder disease and have symptoms before Screen or randomly (such as common bile duct stones, multiple gallbladder stones, etc., unless the gallbladder has been removed and the removal time is ≥6 months);\n* Participants had a history of acute pancreatitis attacks or chronic pancreatitis within 12 months prior to screening or randomization;\n* Subjects with atherosclerotic cardiovascular diseases in the 6 months prior to screening or randomization, including acute coronary syndrome, stable coronary heart disease, post-revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerotic disease, etc., or those diagnosed with a high risk of atherosclerotic cardiovascular disease;\n* There were major cardiovascular and cerebrovascular diseases in the 6 months prior to screening or randomization;\n* Having a history of malignant tumors in the past five years (excluding cured basal cell carcinoma of the skin, localized squamous cell carcinoma of the skin or carcinoma in situ of cervical cancer), or potential malignant tumors currently under assessment;\n* Participants have experienced severe infections within the three months prior to screening, including but not limited to: severe pneumonia, lung abscess, meningitis, cellulitis, etc., and are judged by the researchers as unsuitable to participate in this trial;\n* Participants with poor blood pressure control during the screening period (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg); Or the antihypertensive drugs of the participants have not been stable for ≥3 months before screening or randomization (thiazide diuretics and beta-blockers are prohibited from 3 months before screening to the entire trial period).\n* Participants test positive for any one of hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus antibody;\n* Other lipid regulators (excluding lipid-lowering drugs in inclusion criterion 4) were used from 28 days before screening\u002Frandomization to the entire trial period (≥3 days), including niacin (\\\u003C375 mg\u002F day), over-the-counter or non-pharmaceutical strength fish oil, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterols\u002Fsterol products, polyphenols, etc.\n* In the opinion of the investigator, the participants have symptoms such as dermatitis or abnormal skin around the abdominal administration site;\n* Participants with a history of severe drug or food allergies, who have used immunosuppressant drugs, or who are determined by the researcher to be allergic to the investigational drug;",{"count":229,"type":21},48,[24,25],"To evaluate the safety and tolerability of multiple subcutaneous injections of JMT202 injection in Chinese participants with hypertriglyceridemia",[233],"Hypertriglyceridemia","2025-12-22",{"date":196,"type":37},{"date":237,"type":37},"2025-09-09",{"date":239,"type":21},"2026-10-01",{"name":43,"class":44},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":256,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":45},"100614090","phase-1-jmt106-injection-in-the-treatment-of-advanced-solid-tumors-100614090","NCT07275073","JMT106 Injection in the Treatment of Advanced Solid Tumors","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Antitumor Activity of JMT106 Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed advanced solid tumor.\n3. Failure of at least one line of standard therapy, or no standard treatment available, or intolerant to standard treatment at the current stage.\n4. At least one measurable lesion according to RECIST 1.1 criteria.\n5. ECOG performance status of 0-1.\n6. Expected survival ≥3 months.\n7. Sufficient organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factor treatment within 14 days):\n\n   1. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL;\n   2. Platelets (PLT) ≥90×10⁹\u002FL;\n   3. Hemoglobin (Hb) ≥90 g\u002FL;\n   4. Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for liver metastases or hepatocellular carcinoma);\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN for liver metastases or hepatocellular carcinoma);\n   6. Creatinine clearance (Ccr) \\>50 mL\u002Fmin (calculated by Cockcroft-Gault formula);\n   7. Activated partial thromboplastin time (APTT) ≤1.5×ULN; INR ≤1.5×ULN.\n8. Fertile participants (male and female) must agree to use reliable contraception (hormonal, barrier, or abstinence) with their partners during the trial and for at least 180 days after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment.\n9. Understand and voluntarily sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Previous treatment with anti-GPC3 therapy.\n2. Presence of spinal cord compression or clinically active central nervous system metastases (untreated or symptomatic metastases, or those requiring corticosteroids\u002Fanticonvulsants for symptom control), or carcinomatous meningitis. Patients with previously treated brain metastases (e.g., whole-brain radiotherapy or stereotactic brain radiotherapy) may be enrolled if clinically stable for ≥4 weeks with no imaging evidence of progressive brain metastases.\n3. Long-term immunosuppressive therapy (e.g., cyclosporine) or daily systemic steroid therapy (e.g., \\>20 mg prednisone or equivalent), excluding those using nasal spray, inhaled, or other topical glucocorticoid therapies.\n4. Adverse reactions from prior antitumor therapy not recovered to CTCAE 5.0 Grade ≤1 (excluding toxicities deemed non-risky by the investigator, e.g., alopecia).\n5. Any antitumor therapy (chemotherapy, targeted therapy, immunotherapy, etc.) or investigational intervention within 4 weeks or 5 half-lives (whichever is shorter) before the first dose, or traditional Chinese medicine with antitumor indications within 14 days prior.\n6. Grade ≥3 immune-related adverse events (irAEs, per CTCAE 5.0) from prior immunotherapy.\n7. Concurrent participation in another interventional clinical trial (observational trials or follow-up phases allowed).\n8. Major surgery within 28 days before the first dose or planned tumor resection during the study.\n9. Significant bleeding tendency within 4 weeks before the first dose, or high-risk conditions (e.g., gastrointestinal hemorrhage, severe hemoptysis) per investigator judgment; hereditary bleeding disorders.\n10. Known severe allergy to the study drug or its excipients.\n11. Active bacterial, fungal, or viral infection requiring IV treatment within 14 days before randomization (prophylactic therapy allowed if no active infection symptoms); patients with viral hepatitis are allowed to receive antiviral treatment.\n12. Uncontrolled effusions (pleural, peritoneal, pericardial) requiring frequent drainage or intervention within 14 days before the first dose (excluding cytologic evaluation of effusions).\n13. History of allogeneic organ or hematopoietic stem cell transplantation.\n14. Immunodeficiency, including HIV-positive status.\n15. HBsAg-positive or HBcAb-positive with HBV-DNA \\>2000 IU\u002FmL; HCV antibody-positive with HCV-RNA positivity.\n16. History of tuberculosis treatment within 2 years before the first dose.\n17. Interstitial lung disease or severe pulmonary dysfunction.\n18. History of inflammatory bowel disease or chronic diarrhea.\n19. Severe cardiovascular\u002Fcerebrovascular disease, including:\n\n    1. Severe arrhythmias\u002Fconduction abnormalities (e.g., ventricular arrhythmias requiring intervention, AV block grade II-III);\n    2. Acute coronary syndrome, congestive heart failure, stroke, or other Grade ≥3 cardiovascular events within 6 months before the first dose;\n    3. NYHA class ≥II or LVEF \\\u003C50%;\n    4. Long QTc syndrome or QTc \\>480 ms (Fridericia formula), or concomitant use of QTc-prolonging drugs;\n    5. Uncontrolled hypertension (systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg at screening).\n20. Other active malignancies within 2 years (except cured localized tumors, e.g., basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, in situ prostate\u002Fcervical\u002Fbreast cancer).\n21. Live vaccination within 28 days before the first dose (inactivated vaccines, e.g., seasonal flu vaccine, allowed).\n22. Pregnancy or lactation.\n23. Other conditions deemed unsuitable by the investigator (e.g., depression history\u002Fcurrent treatment, psychiatric disorders affecting compliance, main portal vein tumor thrombus).",{"count":249,"type":21},200,[24],"This study is the first-in-human Phase I study of JMT106 injection, comprising two phases: Dose escalation with backfill and cohort expansion. The planned study population consists of subjects with advanced solid tumors. The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JMT106 injection as monotherapy in participants with advanced solid tumors",[253,254,255],"Advanced Solid Tumor","Lung Squamous Cell Carcinoma","Hepatocellular Carcinoma",[257],"solid tumor","2025-12-10",{"date":260,"type":37},"2025-12-18",{"date":262,"type":37},"2025-09-25",{"date":264,"type":21},"2028-11-15",{"name":43,"class":44},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":4},"100603260","phase-3-the-study-of-jmt101-combined-with-irinotecan-as-a-3rd-line-treatment-in-metastatic-colorectal-cancer-100603260","NCT07134205","The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer","A Randomized, Open-label, Multicenter Phase III Clinical Study of JMT101 in Combination With Irinotecan in Third-line and Beyond Treatment of Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* 1\\. Age ranged from 18 to 75 years old (inclusive), regardless of gender;\n* 2\\. Pathological diagnosis as metastatic colorectal adenocarcinoma, with RAS and BRAF wild-type and non-dMMR\u002FMSI-H;\n* 3\\. Tumor tissue available for central laboratory testing;\n* 4\\. Metastatic colorectal cancer with disease progression after 2nd line treatment; previously received standard chemotherapy based on fluorouracil, oxaliplatin, irinotecan; patients are allowed to previously receive EGFR and\u002For VEGF inhibitors, but not allowed to previously receive regorafenib, fruquintinib;\n* 5\\. Measurable disease according to RECIST1.1;\n* 6\\. Eastern Cooperative Oncology Group (ECOG) score 0-1 points;\n* 7\\. Life expectancy ≥3 months\n* 8\\. Adequate main organs and bone marrow function.\n* 9\\. Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Participants who have been systematically treated with an EGFR inhibitor (such as cetuximab) within 4 months prior to the first dose of study drug.\n* 2\\. Central nervous system metastasis or meningeal metastasis;\n* 3\\. Patients with high risk of bleeding due to tumor invasion of important arteries;\n* 4\\. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;\n* 5\\. The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1;\n* 6\\. Diagnosed as a second primary malignant tumor within 5 years prior to the first administration of the study drug;\n* 7\\. Have received anti-tumor treatments such as chemotherapy, biological therapy, targeted therapy, etc. within 21 days before the first dose of the study drug; radiotherapy within 2 weeks before the first dose of the study drug; Chinese medicine or Chinese patent medicine with anti-tumor effect within 1 week before the first dose of the study drug;\n* 8\\. Have received a live viral vaccine or live-attenuated vaccine within 28 days before the first dose of study drug or plan to receive it during the study;\n* 9\\. Use of immunosuppressive medications within 14 days prior to the first dose of study drug;\n* 10\\. Those who use strong CYP3A4 inducers within 14 days before the first administration of the study drug, or those who use strong CYP3A4 inhibitors or strong UGT1A9 inhibitors within 2 week, or those who cannot suspend the use of the above drugs during the study;\n* 11\\. Have received radiation therapy or other localized palliative treatment within 14 days before the first dose of study drug;\n* 12\\. Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;\n* 13\\. Have a history of serious cardiovascular disease;\n* 14\\. Previous or current presence of interstitial pneumonia\u002Flung disease;\n* 15\\. History of autoimmune diseases;\n* 16\\. A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;\n* 17\\. Have infectious diseases requiring systemic anti-infective treatment;\n* 18\\. Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;\n* 19\\. Known presence of hypersensitivity or intolerance to any component of EGFR monoclonal antibody, irinotecan hydrochloride injection, regorafenib and its excipients;\n* 20\\. Women during lactation or pregnancy; women with fertility tested positive for blood pregnancy within 7 days prior to enrollment in the trial;\n* 21\\. Any male and female patients with fertility who refuse to use effective contraceptive methods throughout the entire trial period and within six months after the last administration;\n* 22\\. Other conditions that, in the opinion of the investigator, may affect the safety or compliance of drug treatment in this study, including but not limited to: psychiatric disorders, any severe or uncontrollable diseases, etc.",{"count":274,"type":21},252,[80],"This is a randomized, open-label, multicenter, phase III clinical study. The aim is to evaluate the efficacy of JMT101 in combination with irinotecan in the third-line and beyond treatment of Metastatic Colorectal Cancer.",[278],"Metastatic Colorectal Cancer (mCRC)","2025-08-14",{"date":281,"type":37},"2025-08-21",{"date":283,"type":21},"2025-10-01",{"date":285,"type":21},"2028-10-01",{"name":43,"class":44},{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100595183","phase-2-a-study-to-learn-more-about-the-effects-and-safety-of-jmt601-in-adults-with-primary-membranous-nephropathy-100595183","NCT07029139","A Study to Learn More About the Effects and Safety of JMT601 in Adults With Primary Membranous Nephropathy","A Multicenter, Randomized, Controlled, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JMT601 Injection in Participants With Primary Membranous Nephropathy","Inclusion Criteria:\n\n1. The age range is between 18 and 80 years old, regardless of gender.\n2. Diagnosed with primary membranous nephropathy by renal biopsy during the screening\u002Finduction period or within 24 months before screening. Pathological reports must be reviewed by the investigator prior to study drug administration.\n3. The glomerular filtration rate (eGFR) estimated by CKD-EPI formula is ≥ 40ml\u002Fmin\u002F1.73m\\^2, or the endogenous creatinine clearance rate (CrCl) based on 24-hour urine examination is ≥ 40ml\u002Fmin.\n4. Participants taking angiotensin converting enzyme inhibitors\u002Fangiotensin II receptor antagonists must maintain a stable dose for at least 4 weeks before screening;\n5. Participants with systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening.\n6. During the screening period and the baseline visit, the 24-hour urine protein is \\> 3.5g.\n7. Have never received immunosuppressive therapy for PMN (cyclophosphamide, calcineurin inhibitors, such as cyclosporine and tacrolimus) and B cell exhaustion therapy (such as rituximab); or relapsed after receiving the above treatment to achieve complete remission or partial remission (comprehensively judged and recorded by the researcher), and have not received the above treatment after recurrence (excluding those who are ineffective or resistant to B cell depletion drugs).\n8. Have fully understood this study and voluntarily signed the informed consent form.\n\nExclusion Criteria:\n\n1. Secondary membranous nephropathy.\n2. Diagnostic renal biopsy shows evidence of glomerular crescent formation, which suggests the diagnosis of other renal diseases or renal biopsy evidence of interstitial fibrosis\u002Ftubular atrophy in cortical area \\> 50%.\n3. Uncontrolled blood pressure as judged by the investigator within the 3 months prior to screening.\n4. Individuals with evidence of a ≥50% decrease in urine protein within the first 6 months before screening.\n5. Currently undergoing or planning to undergo renal replacement therapy during the study period.\n6. Type 1 diabetes or type 2 diabetes with diabetic nephropathy (confirmed by renal biopsy report) or without biopsy-confirmed diabetic nephropathy but with a diabetes duration ≥5 years.\n7. Presence of severe, progressive, or uncontrolled comorbidities.\n8. Individuals who have had or currently have malignant tumors.\n9. Participants with autoimmune diseases requiring systemic immunosuppression therapy, or those judged by researchers to have autoimmune diseases that interfere with the clinical evaluation of primary membranous nephropathy or are not suitable for clinical trials.\n10. A history of previous or current hemolytic anemia, Evans syndrome, arteritis.\n11. Participants with suspected active or latent tuberculosis patients based on medical history or tuberculosis screening.\n12. Severe active bacterial, viral, fungal, mycobacterial, parasitic, or other infections requiring systemic antibiotics or antiviral treatment within 1 month before screening.\n13. Have received prescribed treatment for membranous nephropathy before screening.\n14. Participants using of complementary therapies that may interfere with the investigator's assessment of participant efficacy and safety within 4 weeks prior to randomization.\n15. Live vaccines or major surgery within 28 days before the investigational drug administration or undergoing major surgery.\n16. Participants who have participated in clinical trials of other drugs with a screening time less than 30 days from the last administration or the five half-lives of the original drug (whichever is longer), or those who plan to participate in clinical trials of another drug during the study period.\n17. Participants who have received targeted CD47 or signal regulatory protein α (SIRPα) therapy.\n18. A history of alcoholism or drug abuse within 12 months.\n19. Virology test results at screening meet the criteria:\n\n    HBsAg positivity; If HBsAg is negative and HBcAb is positive, HBV DNA should be exceeding the upper limit of the local laboratory reference range; Positive hepatitis C virus (HCV) antibody with detectable HCV RNA; Positive serology for human immunodeficiency virus (HIV).\n20. Any of the following abnormal laboratory test results during screening: hemoglobin\\\u003C80g\u002FL, platelet count\\\u003C100× 10\\^9\u002FL , absolute neutrophil count\\\u003C1.5× 10\\^9\u002FL , AST or ALT values\\>2× upper limit of normal (ULN), CD4+ T lymphocyte count \\\u003C 300 cells\u002FμL, QTcF\\>450 ms for males and \\>460 ms for females.\n21. Participants who have previously shown resistance to CD20 inhibitors or cyclosporine.\n22. Known history of severe hypersensitivity reactions to humanized monoclonal antibodies or documented allergy to any component of rituximab (dose-escalation part only), JMT601 injection, or cyclosporine (dose-expansion part only).\n23. Pregnant or lactating women; Women of childbearing potential not undergoing sterilization who are unwilling to use adequate contraception during treatment and for at least 6 months after the last dose of the investigational drug.\n24. Men not undergoing sterilization who are unwilling to use barrier contraception during the study and for at least 6 months after the last dose of the investigational drug, and who refuse to ensure their partners use additional contraceptive methods (e.g., oral contraceptives, intrauterine devices, barrier methods, or spermicides).\n25. Other conditions that the investigator deems render the subject unsuitable for study participation.","80 Years",{"count":296,"type":21},156,[25],"This study is a multicenter, randomized, controlled, open-label, Phase Ⅱ clinical study to evaluate the efficacy, safety, Pharmacokinetics characteristics, Pharmacodynamics effects, and immunogenicity of JMT601 in participants with primary membranous nephropathy.\n\nThe study has two parts. Part one is dose escalation part, and Part two is dose expansion part.",[300],"Primary Membranous Nephropathy","2025-06-11",{"date":303,"type":37},"2025-06-19",{"date":305,"type":21},"2025-06-30",{"date":307,"type":21},"2029-03-01",{"name":43,"class":44},{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":45},"100503654","phase-3-efficacy-and-safety-of-kn026-in-combination-with-hb1801-in-the-first-line-treatment-of-subjects-with-her2-positive-recurrent-or-metastatic-breast-cancer-100503654","NCT05838066","Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.","A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.","Key Inclusion Criteria:\n\n* Voluntarily enrolled in this study and signed an informed consent form (ICF).\n* Age ≥ 18 years.\n* Recurrent or metastatic breast cancer confirmed by histology and\u002For cytology.\n* Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.\n* No prior systemic chemotherapy and\u002For HER2-targeted therapy for recurrent or metastatic breast cancer.\n* Eastern Cooperative Oncology Group (ECOG) physical status score of 0 - 1.\n* Presence of lesion (RECIST 1.1).\n* Adequate organ and bone marrow function\n\nKey Exclusion Criteria:\n\n* Ineligible for any of the agents on the study\n* Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis.\n* Pregnant or lactating women.\n* Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.",{"count":317,"type":21},880,[80],"This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).",[321],"First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer","2025-05-26",{"date":324,"type":37},"2025-05-30",{"date":326,"type":37},"2023-07-23",{"date":328,"type":21},"2027-12-31",{"name":43,"class":44},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":4},"100592848","phase-2-jskn003-combined-treatment-of-her2-positive-gastric-cancer-100592848","NCT06998771","JSKN003 Combined Treatment of HER2-positive Gastric Cancer","A Phase II Trial to Evaluate the Safety and Efficacy of JSKN003 Combination Therapy as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Gastric Cancer or Resectable Gastric Cancer","Inclusion Criteria:\n\n* Age≥18 years old.\n* Histologically or cytologically confirmed diagnosis of gastric cancer.\n* The first-line population enrolls participants with HER2-positive unresectable locally advanced or metastatic gastric cancer who had not received systemic treatment, and Perioperative population enrolls participants with HER2-positive resectable gastric cancer who had not received treatment.\n* HER2-positive (defined as IHC3+ or IHC 2+\u002FFISH +).\n* The first-line population: presence of at least 1 measurable lesion per RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* ECOG PS of 0 - 1.\n* Expected survival ≥ 3 months.\n* Participants with adequate organ functions.\n* Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 7 months after the last dose. Female participants of childbearing age must have a negative blood pregnancy test within 7 days before the first dose or randomization.\n* Voluntarily agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Has received anti-tumor treatment such as systemic chemotherapy or other trial interventions within 28 days, or immunotherapy (e.g. interleukin, interferon, thymospipeptide, etc.), hormone therapy or targeted therapy within 14 days or 5 half-life (whichever is shorter) before the first dose or randomization.\n* Has previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors.\n* Participants with brain metastasis or spinal cord compression at screening (except for completed local treatment and discontinued glucocorticoids for at least 4 weeks before the first dose or randomization , and stable central nervous system imaging and brain metastasis symptoms for at least 4 weeks).\n* Participants with PD-L1 CPS ≥1, who are receiving long-term immunotherapy (e.g., cyclosporine) or require daily systemic steroid therapy (e.g., \\>20 mg prednisone or equivalent), except those who treated with local glucocorticoids using nasal spray, inhalation, or other pathways.\n* Participants with PD-L1CPS ≥1, who have an active autoimmune disease or have a history of autoimmune disease 2 years before the first dose or randomization and still require systemic treatment. However, participant with the following diseases is allowed to enroll: well-controlled type I diabetes, well-controlled hypothyroidism that requires hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or participant who is expected to not recur without external triggers.\n* Participate in another clinical trial, unless it is an observational (non-intervention) clinical trial or is in the follow-up period of an intervention trial.\n* Participants who have undergone major surgery or had invasive intervention within 28 days before the first dose or randomization. Or those who plan to undergo systematic or local tumor resection during the trial (Perioperative cohort does not apply).\n* Any Chinese patent medicine with anti-cancer activity approved by the National Drug Administration (regardless of cancer type) has been used within 14 days before the first dose or randomization.\n* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.\n* Active bacterial, fungal or viral infection before the first dose or randomization. Participant who has recieved preventive infection treatment but has no clinical manifestations before the first dose or randomization could be considered to enroll.\n* Has a history of immunodeficiency, including HIV-positive.\n* Active hepatitis B or C infection. Participant with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) need to test Hepatitis B virus DeoxyriboNucleic Acid (HBV-DNA), and HBV-DNA is higher than 500 IU\u002FmL (or 2500 copies\u002Fml) or upper limit of normal (UNL) (whichever is lower) ; Participants with positive for hepatitis C (HCV) antibody and whose Hepatitis C virus Ribonucleic Acid (HCV-RNA) is higher than 1000 copies\u002Fml or UNL (whichever is lower).\n* Has a history of tuberculosis treatment within 2 years before the first dose or randomization.\n* Has activity or a history of interstitial lung disease at any stage and\u002For pulmonary function injury, a history of interstitial pneumonia requiring hormone therapy, or the imaging cannot rule out suspected interstitial lung disease\u002Fpneumonia at screening.\n* Known to have low activity or lack of dihydropyrimidine dehydrogenase (DPD).\n* Participants with peripheral neuropathy of grade \\> 1.\n* Participants with clinically significant gastrointestinal diseases including but not limited to severe liver diseases, ulcerative colitis, inflammatory bowel disease and other gastrointestinal diseases 28 days before the first dose or randomization.\n* Has a history of severe cardiovascular disease.\n* History of any other malignant tumors within 5 years before the first dose or randomization.\n* Live vaccination within 28 days before the first dose or randomization. Note: Seasonal influenza vaccine is a broadly inactivated vaccine and is allowed to be used;\n* Unable to swallow orally, or there are conditions that have been judged by researchers to seriously affect gastrointestinal absorption (such as severe Crohn's disease, malabsorption syndrome, etc.).\n* Pregnant or breastfeeding women.\n* Otherwise considered inappropriate for the study by the investigator.",{"count":338,"type":21},153,[25],"This study is designed to evaluate the safety and efficacy of JSKN003 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer or resectable gastric cancer.",[191],"2025-05-22",{"date":344,"type":37},"2025-05-31",{"date":346,"type":21},"2025-06-15",{"date":348,"type":21},"2029-12-31",{"name":43,"class":44},{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":45},"100573519","phase-3-a-phase-iii-study-of-kn026-in-combination-with-hb1801--carboplatin-as-neoadjuvant-treatment-for-early-or-locally-advanced-her2-positive-breast-cancer-100573519","NCT06747338","A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer","A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Trial to Compare the Efficacy and Safety of KN026 Combined With HB1801 ± Carboplatin Versus Trastuzumab Combined With Pertuzumab and Docetaxel ± Carboplatin in Neoadjuvant Treatment of Early or Locally Advanced HER2-positive Breast Cancer.","Neo-Healer","Inclusion Criteria:\n\n1. Voluntarily participate in the experiment and sign the informed consent;\n2. Aged \\>= 18 years;\n3. Histologically and cytologically confirmed primary invasive carcinoma of the breast with early (T2-3, N0-1, M0) or locally advanced stage (T2-3, N2-3, M0; T4, any N, M0) (AJCC 8th Edition);\n4. ECOG PS 0-1;\n5. HER2 positive (HER2+++ by IHC or HER2++ by IHC and ISH+);\n6. Agree to receive surgical treatment for breast cancer in the participating research unit when the surgical standard is reached after neoadjuvant therapy;\n7. Adequate organ and bone marrow function (no blood transfusions or hematopoietic stimulating factor classes within 14 days prior to the test);\n8. Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and\u002For partner for the duration of the study treatment and for at least 3 months (Docetaxel and HB1801) or 7 months (Pertuzumab, trastuzumab, KN026, and Carboplatin) after the last dose of study drug;\n\nExclusion Criteria:\n\n1. Inflammatory or bilateral breast cancer;\n2. History of non-breast malignancies within the 3 years prior to study entry, except for carcinoma in situ of the cervix or breast, and basal cell and squamous cell carcinomas of the skin, etc.;\n3. The researchers determine that there are contraindications for breast cancer surgery;\n4. Participants who underwent primary lumpectomy and\u002For axillary lymph node dissection biopsy prior to randomization (except for diagnostic biopsy of primary breast cancer or surgery for benign breast tumors);\n5. Any previous systemic chemotherapy, endocrine therapy or anti HER2 biological therapy or local radiotherapy for breast cancer;\n6. Sensitivity to any of the study medications or any of the ingredients or excipients of these medications;\n7. Participants with known allergies and\u002For contraindications to glucocorticoids;\n8. Have a congenital or acquired immune deficiency (such as HIV infection); 9 . Serious cardiac or cardiovascular disease or condition; 10 Serious chronic or active infections requiring intravenous antimicrobial, antifungal, or antiviral therapy were present within 14 days prior to randomization.\n\n11\\. Patients who had undergone major organ surgery (excluding biopsy) within 28 days before randomization and have not fully recovered.\n\n12\\. Potent inhibitors or inducers of CYP3A4 were used within 14 days before randomization or continued use was required.\n\n13\\. Being enrolled in other clinical trials (except for non-interventional clinical trials or a follow-up period in an interventional trial) or at randomization was less than 4 weeks from the end of the previous clinical trial (end of treatment).\n\n14\\. Pregnant or lactating. 15. The existence of other conditions that may interfere with the participant's study procedures or that do not correspond to the participant's maximum benefit from participating in the study or to the findings of the imaging study, such as a history of neurological or mental illness, alcohol abuse, drug use or substance abuse, any other disease or condition of clinical significance.",{"count":359,"type":21},520,[80],"This randomized, controlled, open-label, multicenter study will evaluate the safety and efficacy of KN026 in combination with HB1801 ± Carboplatin as neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer.",[363],"Early or Locally Advanced HER2-positive Breast Cancer","2025-04-18",{"date":366,"type":37},"2025-04-24",{"date":368,"type":37},"2024-12-16",{"date":370,"type":21},"2027-12-16",{"name":43,"class":44},{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":45},"100579835","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-glumetinib-combined-with-osimertinib-mesylate-versus-platinum-based-doublet-chemotherapy-in-non-small-cell-lung-cancer-patients-after-resistance-to-egfr-tkis-100579835","NCT06829459","A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs","A Randomized, Controlled, Open-label Phase III Clinical Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients With MET Amplification and\u002For Overexpression After Resistance to EGFR-TKIs","Inclusion Criteria:\n\n* 1\\. Patients who are able to understand and voluntarily sign the written ICF; 2. Male or female patients aged ≥ 18 years (inclusive); 3. Patients with histologically or cytologically confirmed NSCLC, which is unresectable locally advanced or metastatic (Stage ⅢB, ⅢC, or Ⅳ) NSCLC according to the 8th edition of the TNM Staging System by the International Association for the Study of Lung Cancer (IASLC). Note: If the pathological type is mixed, it should be classified by primary cell type. However, if there are small cell components or neuroendocrine carcinoma components, enrollment will be not allowed; 4. Patients with EGFR-sensitive mutations confirmed by tumor histology or cytology or hematology before the first-line treatment with EGFR-TKIs; 5. Patients who have experienced documented imaging PD after treatment with first-, second- or third-generation EGFR-TKIs (gefitinib, erlotinib, icotinib, afatinib, dacomitinib, osimertinib, etc.); patients who have received prior adjuvant EGFR-TKI treatment after radical surgery may be enrolled if they have had PD within 6 months after the last dose of EGFR-TKIs.\n\n  6\\. Patients with PD following EGFR-TKI treatment who meet any of the following requirements: a. EGFR T790M negative with MET amplification and\u002For overexpression after PD following treatment with first- or second-generation EGFR-TKIs; b. MET amplification or overexpression after PD following treatment with third-generation EGFR inhibitors; MET amplification or overexpression in tumor tissue samples as confirmed by the sponsor-designated central laboratory (meeting one of the following conditions):\n  1. IHC: 3 +, ≥ 90%\n  2. FISH: GCN ≥ 5 or MET\u002FCEP7 ratio ≥ 2 7. Patients who have at least one measurable lesion meeting the RECIST v1.1 criteria. Lesions that have previously undergone local treatments such as radiotherapy can be considered as target lesions upon confirmed progression. Brain metastases will not be considered as target lesions.\n\n     Exclusion Criteria:\n* 1\\. Patients with prior treatment with targeted MET drugs; 2. Patients with T790M-positive mutation after PD following treatment with first- or second-generation EGFR-TKIs; 3. Patients who are positive for other driver genes, such as ALK\u002FROS1 positive after PD following EGFR-TKI treatment; 4. Patients with prior systemic anti-tumor therapy (including chemotherapy and immunotherapy) for advanced NSCLC other than EGFR-TKIs;",{"count":380,"type":21},350,[80],"The is a randomized, controlled, open-label Phase III clinical study to evaluate the efficacy and safety of glumetinib combined with osimertinib mesylate versus platinum-based doublet chemotherapy in non-small cell lung cancer( NSCLC) patients with MET amplification and\u002For overexpression after resistance to EGFR-TKIs..\n\nApproximately 350 NSCLC patients with MET amplification and\u002For overexpression after previous treatment with EGFR-TKIs are planned to be enrolled. After patients sign the informed consent form (ICF), those who are eligible for enrollment after screening examinations will be randomized to the investigational group or the control group in a 1:1 ratio by the central randomization system (IWRS).",[105],"2025-04-06",{"date":386,"type":37},"2025-04-08",{"date":388,"type":37},"2025-04-03",{"date":390,"type":21},"2029-02-15",{"name":43,"class":44},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":4},"100585930","phase-2-glumetinib-combined-with-osimertinib-treatment-for-non-small-cell-lung-cancer-patients-100585930","NCT06908772","Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients","A Multicenter Phase II\u002FIII Clinical Study on the Efficacy and Safety of Glumetinib Combined With Osimertinib as First-Line Treatment in Non-Small Cell Lung Cancer Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression","Inclusion Criteria:\n\n* 1\\. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Male or female subjects aged 18 to 75 years (inclusive). 3. Patients with NSCLC who have unresectable locally advanced or metastatic disease; 4. At least one measurable lesion, as defined by RECIST 1.1 criteria; 5. ECOG performance status of 0 or 1; 6. Expected survival ≥ 3 months; 7. Adequate function of major organs and bone marrow; 8. Women or man of childbearing potential must use highly effective contraception.\n\nExclusion Criteria:\n\n1. Prior treatment with an EGFR inhibitor or MET inhibitor;\n2. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;\n3. Patients who have taken strong inducers or inhibitors of CYP3A4 within 2 weeks prior to the first dose of the study drug, or who cannot discontinue the use of strong CYP3A4 inducers and inhibitors during the study;\n4. Patients with a history of autoimmune diseases, a history of immunodeficiency, including positive for HIV, or other acquired or congenital immunodeficiency diseases, or a history of organ transplant;\n5. Presence of active infection (e.g., subjects are receiving anti-infection therapy);\n6. Severe or uncontrolled cardiovascular disorder requiring treatment;\n7. Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;\n8. Women who are pregnant or breastfeeding;",{"count":400,"type":21},390,[25,80],"To evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic NSCLC.",[404],"Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression","2025-03-27",{"date":388,"type":37},{"date":408,"type":21},"2025-04-01",{"date":410,"type":21},"2030-01-31",{"name":43,"class":44},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":430,"leadSponsor":432,"locationsCount":4},"100584675","phase-2-jmt101-combined-with-mitoxantrone-liposome-for-nasopharyngeal-cancer-100584675","NCT06892431","JMT101 Combined With Mitoxantrone Liposome for Nasopharyngeal Cancer","A Phase II Clinical Study of JMT101 Injection Combined With Mitoxantrone Liposome Injection in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Cancer Who Have Failed At Least Two Prior Lines of Treatment","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign the written ICF;\n2. Aged 18-75 years old (inclusive), male or female;\n3. Patients with nasopharyngeal cancer who have experienced treatment failure after prior PD-(L)-1 inhibitor therapy and at least second-line chemotherapy (including at least one line containing platinum);\n4. According to RECIST v1.1, there is at least one measurable lesion, and the lesion has not previously undergone radiotherapy or has shown definite progression after radiotherapy;\n5. ECOG PS score of 0-1;\n6. Estimated lifespan of at least 3 months;\n7. Have adequate organ function, laboratory test meets the following criteria (has not received transfusion or hematopoietic stimulating factor treatment within 14 days):(1)Hematology: a. Absolute neutrophil count ≥1.5×109\u002FL; b. Platelet count ≥100×109\u002FL; c. Hemoglobin ≥90 g\u002FL.(2)Liver function: a. Total bilirubin ≤1.0×ULN; for participants with metastases to liver, total bilirubin ≤1.5×ULN; b. Alanine aminotransferase and aspartate aminotransferase ≤1.5×ULN, for participants with metastases to liver, alanine aminotransferase and aspartate aminotransferase ≤2.5×ULN. (3)Renal function: Creatinine ≤1.5×ULN; or creatinine clearance ≥50 mL\u002Fmin (calculated according to the Cockcroft-Gault formula).(4)Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN; activated partial thromboplastin time (APTT) ≤ 1.5×ULN;\n8. Women of childbearing potential must use highly effective contraception.\n\nExclusion Criteria:\n\n1. Previously received EGFR monoclonal antibody therapy for recurrent\u002Fmetastatic nasopharyngeal cancer;\n2. Have previously received treatment with doxorubicin or other anthracyclines, and the cumulative dose of doxorubicin exceeds 350 mg\u002Fm2 (Equivalent dose calculation for anthracyclines: 1 mg doxorubicin = 2 mg epirubicin = 2 mg daunorubicin = 0.5 mg idarubicin = 0.45 mg mitoxantrone);\n3. History of drug allergy to the active or inactive excipients of any study drug, or to drugs with similar chemical structure or class as these two drugs;\n4. Have received anti-tumor treatments within 2 weeks prior to the first dose of study drug, including hormone therapy, biological therapy, immunization therapy, local perfusion of anti-tumor drugs, or traditional Chinese medicines and\u002For Chinese patent drugs indicated for the treatment of nasopharyngeal cancer;\n5. Have received local radiotherapy (including radionuclide therapy such as strontium-89) within 2 weeks prior to the first dose of study drug; have received irradiation of more than 30% of bone marrow or have received wide-field radiotherapy within 4 weeks prior to randomization;\n6. Uncontrolled serous cavity effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose;\n7. Have undergone major surgery or had severe traumatic injury within 4 weeks prior to the first dose of study drug, or it is expected to undergo major surgery during the study period. Some clinical procedures such as vascular access placement and aspiration biopsy are allowed;\n8. Currently receiving long-term immunosuppression therapy (e.g., cyclosporine) or have other diseases requiring treatment with systemic corticosteroids (i.e., prednisone over 10 mg\u002Fday or other corticosteroids at equivalent physiological doses), excluding those receiving local glucocorticoid therapy via nasal spray, inhalation, or other routes;\n9. Participants with metastases to meninges or spinal cord compression; participants with symptomatic and\u002For unstable brain metastasis, unless the participant has completed definitive treatment and has been stable for at least 2 weeks prior to randomization without the need for steroid therapy. Participants with asymptomatic brain metastases may be enrolled if the investigator assesses that there is no indication for immediate curative treatment;\n10. Subjects who have taken strong CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose of study drug, or who cannot suspend the use of strong CYP3A4 inducers and inhibitors during the study;\n11. Participants with a history of autoimmune diseases, a history of immunodeficiency, including positive for HIV, or other acquired or immunodeficiency congenital diseases, or a history of organ transplant;\n12. Presence of active infection (e.g., the subject is receiving anti-infection therapy), including uncontrolled active hepatitis b, active hepatitis c, active syphilis, active tuberculosis, etc.; Patients with a history of human hepatitis B virus (HBV) infection may be considered for enrollment if they meet all of the following criteria: a. Have no co-infection with hepatitis C virus (HCV) and no history of HCV infection; b. Participants with active HBV infection may also be enrolled if they can receive at least 2 weeks of antiviral therapy before starting study treatment, and after treatment their HBV DNA is less than 100 IU\u002FmL and transaminases are less than 1×ULN.\n13. Severe or uncontrolled cardiovascular disorder requiring treatment, including but not limited to\n14. Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally, or previous subtotal small bowel resection, etc., and have conditions that seriously affect gastrointestinal absorption as judged by the investigator.\n15. Prior to initiating treatment, have not yet adequately recovered (i.e., to ≤ Grade 1, excluding hypodynamia or alopecia) from toxicities and\u002For complications caused by any interventions;\n16. Participants with other malignant tumors currently or with a history of other active malignant tumors within 5 years prior to the first study treatment (except for clinically cured localized tumors;\n17. History of interstitial lung disease (ILD), history of drug-induced ILD, history of radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD;\n18. Women who are pregnant or breastfeeding;\n19. The researchers believe that the subjects are not suitable to participate in this clinical study due to other reasons.",{"count":420,"type":21},150,[25],"This study is a randomized, open-label, multicenter Phase II clinical study, with the objective to assess the efficacy and safety of JMT101 Injection combined with Mitoxantrone Hydrochloride Liposome Injection in patients with recurrent\u002Fmetastatic nasopharyngeal cancer who have failed at least two prior lines of treatment.",[424,425],"Recurrent or Metastatic Nasopharyngeal Cancer","Patients Who Have Experienced Treatment Failure at Least Second-line Chemotherapy","2025-03-23",{"date":428,"type":37},"2025-03-25",{"date":408,"type":21},{"date":431,"type":21},"2027-04-30",{"name":43,"class":44},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":45},"100581140","phase-3-jskn003-versus-trastuzumab-emtansine-t-dm1-for-her2-positive-advanced-breast-cancer-100581140","NCT06846437","JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer","A Randomized, Controlled, Open-Label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer Subjects","Inclusion Criteria:\n\n* 1\\. Voluntarily agree to participate in the study and sign the informed consent.\n* 2.Age≥18 years old.\n* 3.Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology.\n* 4.Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive) by the pathology department of participating study center.\n* 5.Have received treatment regimen including trastuzumab (allowed marketed trastuzumab biosimilars) or inetetamab with radiologic or pathologic progression\u002F relapse during the advanced stage, during neoadjuvant or adjuvant therapy, or within 12 months after treatment.\n* 6.Previously treated with taxanes.\n* 7.Had radiologic and\u002For pathologic progression or intolerance of the latest systemic anti-tumor therapy.\n* 8.At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.\n* 9.ECOG PS of 0 - 1.\n* 10.Patients with adequate organ and bone marrow functions.\n* 11.Expected survival ≥ 3 months.\n* 12.Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 7 months after the last dose of JSKN003 or T-DM1.\n\nExclusion Criteria:\n\n* 1\\. Have previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors or medenosin derivative 1 (DM1) or have relapsed after receiving such therapy during or within 12 months after the adjuvant\u002Fneo-adjuvant setting or in the advanced stage.\n* 2.History of any other malignant tumors within three years before randomization.\n* 3.With uncontrollable serous effusion within 14 days before randomization, which requires frequent drainage or medical intervention.\n* 4.Known contraindication to T-DM1or not suitable to receive JSKN003 or T-DM1 by investigator.\n* 5.Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ Grade 1 (refer to NCI CTCAE 5.0) or baseline (excluding grade 2 alopecia, hyperpigmentation, simple laboratory test abnormalities, and other toxicity for a non-safety risk by investigators).\n* 6.Received immunotherapy, macromolecular targeted therapy or other anti-tumor biological therapy within 4 weeks before randomization, or received palliative radiotherapy, endocrine therapy, cytotoxic drug chemotherapy and small molecular targeted drug therapy within 2 weeks before randomization, or received traditional Chinese medicine preparations with anti-tumor indications within 2 weeks before randomization.\n* 7.Major organ surgery within 28 days before randomization.\n* 8.Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.\n* 9.The cumulative amount of previous exposure to anthracyclines has reached the pre-specified dosage.\n* 10.History of LVEF \\\u003C 40% during prior anti-HER2 drug therapy or symptomatic congestive heart failure (CHF).\n* 11.Serious or uncontrolled cardiovascular disease.\n* 12.History of (non-infectious) interstitial lung disease\u002Fpneumonitis requiring therapy or grade ≥3 interstitial lung disease\u002F pneumonitis during previous anti-tumor treatments.\n* 13.Active infections requiring intravenous antibiotics, antivirals, or antifungals within 14 days before randomization.\n* 14\\. Active hepatitis B or hepatitis C.\n* 15.History of immunodeficiency or HIV antibody test positive at screening.\n* 16.Received a potent inhibitor of CYP3A4 within 14 days prior to randomization or during study treatment.\n* 17.Pregnant or nursing females;\n* 18.Other reasons enrolled in this clinical trial as considered unsuitable by the investigator.",{"count":441,"type":21},228,[80],"This study is designed to compare the safety and efficacy of JSKN003 versus T-DM1 in unrespectable locally advanced and\u002For metastatic HER2-positive breast cancer participants previously treated with trastuzumab and taxane.",[445],"Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants","2025-03-19",{"date":448,"type":37},"2025-03-24",{"date":450,"type":37},"2025-02-18",{"date":452,"type":21},"2028-12-31",{"name":43,"class":44},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":22,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":45},"100572601","phase-3-a-clinical-study-of-jmt101-in-combination-with-osimertinib-versus-osimertinib-alone-as-first-line-treatment-for-patients-with-locally-advanced-or-metastatic-non-squamous-non-small-cell-lung-cancer-nsclc-harboring-epidermal-growth-factor-receptor-egfr-sensitive-mutations-100572601","NCT06735391","A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations","A Phase 3 Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations","Inclusion Criteria:\n\n1. Be able to understand and voluntarily sign the written informed consent form (ICF);\n2. Age ≥ 18 years old, male or female;\n3. Participants with histologically or cytologically (pathology report required) confirmed non-squamous NSCLC that is unresectable and locally advanced or metastatic (stage IIIB, IIIC, or IV) according to the International Association for the Study of Lung Cancer (IASLC) 8th edition TNM staging criteria.\n4. Participants who have no prior systemic anti-tumor therapy (including anti-EGFR targeted therapy, chemotherapy, biotherapy, immunotherapy, or any investigational drug) for locally advanced or metastatic NSCLC and are not amenable to radical surgery or radiotherapy. For participants with recurrent disease after prior surgical treatment who have undergone prior adjuvant and neoadjuvant therapy, it is necessary to confirm that there is no recurrence or metastasis of tumor within 6 months after surgery, and the randomization is \\> 6 months from the end of adjuvant\u002Fneoadjuvant therapy;\n5. Have at least one measurable lesion that meets the RECIST 1.1 criteria at baseline. Target lesions must be either radiation naive or, if previously irradiated, there must be evidence of unequivocal disease progression after radiotherapy. Brain metastases should not be considered as target lesions;\n6. ECOG PS score of 0 or 1;\n7. Expected survival ≥ 3 months;\n8. Have major organ and bone marrow functions that meet the following criteria within 7 days prior to the first dose in a non-intervention state:\n\n1\\) Hematology:\n\n1. Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL (prior to the hematology assessment, there is no treatment with cell growth factors within 7 days, and no treatment with long-acting granulocyte colony-stimulating factor (G-CSF) or pegylated recombinant human granulocyte colony-stimulating factor (PEG-CSF) within 14 days);\n2. Platelets ≥ 90×109\u002FL (there is no platelet transfusion or recombinant human thrombopoietin therapy within 7 days prior to hematology assessment);\n3. Hemoglobin ≥ 90 g\u002FL (there is no red blood cell transfusion\u002Fblood transfusion treatment within 14 days prior to hematology assessment); 2) Renal function: Serum creatinine ≤ 1.5×upper limit of normal (ULN), or creatinine clearance (CrCL) ≥ 50 mL\u002Fmin (using the Cockcroft-Gault formula); 3) Liver function:\n\na. Total bilirubin ≤ 1.5×ULN (or ≤ 3×ULN for participants with Gilbert syndrome or metastases to liver); b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (or AST and ALT ≤ 5×ULN for participants with metastases to liver); 4) Coagulation function:\n\n1. International normalized ratio (INR) ≤ 1.5;\n2. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;\n\nExclusion Criteria:\n\n1. Participants with concomitant mutations such as ALK, ROS1, KRAS, BRAF, RET, MET, NTRK, and HER2, for which targeted drugs are commercially available for clinical treatment, who will not benefit from this clinical study as judged by the investigator; or participants with other mutations who will not benefit from this clinical study as judged by the investigator;\n2. Have received Chinese patent medicine preparations for the treatment of lung cancer as an indication within 2 weeks prior to randomization;\n3. Have received local radiotherapy within 2 weeks prior to randomization; have received more than 30% of bone marrow irradiation or extensive radiotherapy within 4 weeks prior to randomization;\n4. Presence of pericardial effusion (small amount of pericardial effusion stable for ≥ 2 weeks prior to randomization is allowed);\n5. Major surgery or severe traumatic injury within 4 weeks prior to the first study treatment, or anticipation of major surgery during the study. Some clinical procedures such as vascular access placement and aspiration biopsy are allowed;\n6. Participants with meningeal metastases; spinal cord compression; symptomatic and unstable brain metastases, unless the participants have completed curative treatment, are in stable condition for at least 2 weeks prior to randomization and do not require steroid therapy. Participants with asymptomatic brain metastases may be enrolled if the investigator assesses that there is no indication for immediate curative treatment;",{"count":462,"type":21},516,[80],"This is a Phase 3, randomized, positive-controlled, open-label clinical study. The primary objective is to evaluate the efficacy of JMT101 in combination with osimertinib versus osimertinib alone in patients with newly diagnosed locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitive mutations.",[466,467,468],"Locally Advanced or Metastatic Non-squamous NSCLC","Harboring EGFR Sensitive Mutations NSCLC","Previously Untreated Systematically NSCLC","2024-12-13",{"date":368,"type":37},{"date":472,"type":37},"2024-10-23",{"date":474,"type":21},"2029-05-30",{"name":43,"class":44},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":45},"100571843","phase-1-a-study-of-jmt601-in-participants-with-relapsed-or-refractory-cd20-positive-b-cell-non-hodgkin-lymphoma-100571843","NCT06725524","A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma","A Phase 1, Open-Label, Multi-center Study Evaluating the Safety and Tolerability of of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma","Key Inclusion Criteria:\n\n* Participants diagnosed with CD20-positive B-cell non-Hodgkin lymphoma confirmed by histopathology and\u002For cell biology who have previously received 2 or more lines of therapy\n* Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2\n* Participants must have at least one evaluable or measurable lesion according to Lugano 2014 criteria.\n* Expected survival of at least 3 months;\n* Suitable organ and hematopoietic function:\n\n  1. The absolute count of neutrophil (ANC) ≥1.0×109\u002FL;\n  2. Platelets ≥75×10\\^9\u002FL (if bone marrow invasion doesn't exist)\u002F≥50.0×10\\^9\u002FL (if bone marrow invasion exists);\n  3. Hemoglobin ≥90 g\u002FL;\n  4. Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin;\n  5. Total bilirubin ≤1.5×ULN, alanine aminotransferase ≤2.5×ULN, aspartate aminotransferase ≤2.5×ULN; Subjects with liver lesion: TBIL≤3×ULN, ALT≤5×ULN, AST≤5×ULN;\n  6. International Standardized ratio and activated partial thromboplastin time ≤1.5 × ULN;\n\nKey Exclusion Criteria:\n\n* Confirmed central nervous system (CNS) lymphoma.\n* Subjects who have received allogeneic hematopoietic stem cell transplantation (HSCT) or other organ transplantation\n* Those who have previously received targeted CD47 or signal regulatory protein α (SIRRP α) therapy.\n* Previous or current hemolytic anemia, Evans syndrome, arteritis;\n* Subjects with previous or current other malignant tumors;\n* Previous or current history of active autoimmune diseases;\n* Subjects who had undergone major surgery within 4 weeks prior to initial dosing or expected to have major surgery during the study period;\n* HIV infection, active syphilis, hepatitis B surface antigen (HBsAg) positive and HBV-DNA higher than the lower limit or 1000 copies \u002Fml(500 IU\u002Fml), HCV antibody positive and HCV-RNA higher than the lower limit or 1000 copies \u002Fml","70 Years",{"count":485,"type":21},186,[24],"This is a Phase 1, open-label, multi-center study to evaluate the safety of JMT601 in the treatment of relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for Phase 2 studies (RP2D). Study consists of 2 parts. The first part is a dose-escalation part using a 3+3 design with up to 6 dose(0.3 mg\u002Fkg, 1 mg\u002Fkg, 3 mg\u002Fkg, 6 mg\u002Fkg, 12 mg\u002Fkg and 20 mg\u002Fkg) escalation cohorts at increasing levels. The second part is a dose-expansion part at R2PD dose to assess preliminary efficacy of JMT601.",[489],"B-cell Non Hodgkin Lymphoma","2024-12-09",{"date":492,"type":37},"2024-12-10",{"date":494,"type":37},"2021-10-12",{"date":496,"type":21},"2025-12-31",{"name":43,"class":44},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":505,"targetDuration":4,"studyType":22,"phases":507,"briefSummary":508,"conditions":509,"keywords":511,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":4},"100545318","phase-3-jmt101-in-combination-with-osimertinib-versus-cisplatin-pemetrexed-in-participants-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-nsclc-characterized-by-epithermal-growth-factor-receptor-egfr-exon-20ins-mutations-100545318","NCT06380348","JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations","A Randomized, Open-label, Parallel-controlled Phase 3 Study of Combination JMT101 and Osimertinib Compared With Cisplatin -Pemetrexed in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age between 18-75 years old.\n2. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the IASLC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy. For central laboratory confirmation of EGFR exon 20 insertion mutation with tumour tissue\u002Fblood sample.\n3. At least 1 measurable lesion per RECIST Version 1.1\n4. Life expectancy ≥ 12 weeks\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n6. Adequate organ and hematologic function\n\nExclusion Criteria:\n\n1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.\n2. Central nervous system metastasis with associated symptom and signs.\n3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.\n4. History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy\n5. As judged by the investigator, unsuitable for attending the study.",{"count":506,"type":21},398,[80],"This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.\n\nPrimary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with\u002Fwithout) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1).",[510],"Local Advanced or Metastatic NSCLC",[512,513],"Harboring EGFR 20ins mutation","Without prior systemic therapy","2024-04-18",{"date":516,"type":37},"2024-04-23",{"date":518,"type":21},"2024-04-26",{"date":520,"type":21},"2028-03-26",{"name":43,"class":44},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":4},"100540628","phase-2-efficacy-and-safety-of-jmt101-combined-wth-docetaxel--hb1801-in-patients-with-squamous-cell-non-small-cell-lung-cancer-100540628","NCT06319313","Efficacy and Safety of JMT101 Combined Wth Docetaxel \u002F HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer","A Randomized, Controlled, Open-label Phase II\u002FIII Study of The Safety, Tolerability and Efficacy of JMT101 Combined With Docetaxel \u002F HB1801 in Patients With sqNSCLC","Inclusion Criteria:\n\n1. Age ranged from 18 to 75 years old (inclusive), regardless of gender;\n2. Pathological diagnosis as sqNSCLC, with EGFR highly expressed, without other driver genes\n3. Tumor tissue available for central laboratory testing;\n4. Disease progression after prior anti PD-1\u002FPD-L1 and platinum containing chemotherapy\n5. Measurable disease according to RECIST1.1;\n6. Eastern Cooperative Oncology Group (ECOG) score 0-1 points;\n7. Life expectancy ≥3 months\n8. Adequate main organs and bone marrow function.\n9. Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Previously used anti EGFR, or docetaxel;\n2. Central nervous system metastasis or meningeal metastasis;\n3. Patients with high risk of bleeding due to tumor invasion of important arteries;\n4. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;\n5. The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1 except for toxicity such as alocepia or fatigue, which is judged to be of no safety risk by researchers;\n6. Diagnosed as a second primary malignant tumor (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ and breast carcinoma in situ, etc.) within 5 years prior to the first administration of the study drug;\n7. Have received anti-tumor treatments such as systemic chemotherapy, biological therapy, immunotherapy, radical radiotherapy chemotherapy, etc. within 28 days before the first dose of the study drug;\n8. Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;\n9. Have received a live viral vaccine or live-attenuated vaccine within 28 days before the first dose of study drug or plan to receive it during the study;\n10. Have received palliative radiotherapy, small molecule targeted therapy, immunomodulatory drugs, NMPA approved modern traditional Chinese medicine preparations and other anti-tumor treatments, within 14 days before the first dose of study drug;\n11. Those who use strong CYP3A4 inducers within 14 days before the first administration of the study drug, or those who use strong CYP3A4 inhibitors within 1 week, or those who cannot suspend the use of the above drugs during the study;\n12. Have a history of serious cardiovascular disease;\n13. Have a history of serious lung disease;\n14. History of autoimmune diseases;\n15. History of immunodeficiency\n16. A history of gastrointestinal perforation and\u002For fistula within 6 months, or gastrointestinal obstruction and active inflammatory bowel disease within 28 days prior to the first study drug administration\n17. Have infectious diseases requiring systemic anti-infective treatment;\n18. Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;\n19. Known hypersensitivity or intolerance to any component of EGFR monoclonal antibody, human serum albumin, docetaxel, and its excipients; Individuals known to be allergic and\u002For contraindicated to glucocorticoids\n20. Women during lactation or pregnancy;\n21. Any male and female patients with fertility who refuse to use effective contraceptive methods throughout the entire trial period and within six months after the last administration;\n22. Other conditions that, in the opinion of the investigator, may affect the safety or compliance of drug treatment in this study, including but not limited to: psychiatric disorders, any severe or uncontrollable diseases, etc.",{"count":530,"type":21},534,[25,80],"This study is a phase II\u002FIII, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel\u002F HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）.",[534],"Squamous Cell Non-small Cell Lung Cancer","2024-03-18",{"date":537,"type":37},"2024-03-20",{"date":539,"type":21},"2024-05-01",{"date":541,"type":21},"2027-12-01",{"name":43,"class":44},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":22,"phases":552,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":4},"100533073","phase-3-a-study-to-assess-the-prevention-of-bone-related-events-in-patients-with-bone-metastases-from-malignant-solid-tumors-treated-with-jmt103-compared-to-zoledronic-acid-100533073","NCT06221072","A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid","A Phase III, Multicenter, Randomized, Double-blind Clinical Trail to Assess JMT103 Compared to Azoledronic Acid for the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age: older than 18 years;\n2. Breast cancer, prostate cancer, lung cancer and other solid tumors diagnosed by histological or cytological examination (prostate patients should also meet: castration-resistant prostate cancer with serum testosterone \\\u003C50 ng\u002FdL or 1.7 nmol\u002FL and serum PSA progression after surgery or drug castration treatment);\n3. Patients with imaging studies showing at least one tumor bone metastasis;\n4. With a good organ function;\n5. Expected survival of at least 6 months.\n\nExclusion Criteria:\n\n1. Previous or ongoing osteomyelitis or osteonecrosis of the jaw; dental or oral surgery; acute dental or jaw disease requiring oral surgery; invasive dental procedures planned during the study; patients with pulpitis during the screening period;\n2. Radiotherapy or surgery for the bone metastases is planned during the study;\n3. Patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo MRI\u002FCT examination to exclude patients with brain metastasis);\n4. Patients with bone metabolic diseases \\[e.g., Paget's disease, Cushing's syndrome, hyperprolactinemia, hyperthyroidism\u002Fhypothyroid (except for hypothyroidism with normal TSH, FT3, and FT4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper\u002Fhypoparathyroidism, etc.\\];\n5. Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes mellitus (≥grade 3, NCI-CTCAE 5.0), symptomatic congestive heart failure, hypertension (BP\\> 150\u002F90 mmHg after standard therapy), unstable angina, arrhythmia requiring medical or instrumental treatment, history of myocardial infarction within 6 months, echocardiography with left ventricular ejection fraction \\\u003C50%;\n6. Treatment with anti-RANKL antibody, bisphosphonates (except for bone scan purposes) within 6 months prior to the first dose;\n7. Patients considered by the investigator as unsuitable for this study (such as poor compliance, etc.).",{"count":551,"type":21},1360,[80],"This is a phase Ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from malignant solid tumors. The purpose of this study is to determine if JMT103 is non-inferior to zoledronic acid.",[555],"Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors","2024-01-14",{"date":558,"type":37},"2024-01-24",{"date":560,"type":21},"2024-04-05",{"date":562,"type":21},"2028-05-31",{"name":43,"class":44},""]