[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangsu Alphamab Biopharmaceuticals Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":344},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,43,67,88,115,136,157,178,201,221,242,264,283,301,325],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100638181","phase-1-a-phase-i-study-of-jskn021-in-advanced-solid-tumors-100638181",false,"NCT07617727","A Phase I Study of JSKN021 in Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form.\n2. Age ≥ 18 and ≤ 75 years old, male or female.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n4. Expected survival ≥ 3 months.\n5. Histologically or cytologically confirmed malignant solid tumors confirmed by histology and\u002For cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.\n6. At least one measurable lesion at baseline according to RECIST 1.1 criteria.\n7. Adequate organ function.\n8. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.\n9. Female subjects of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days before the first dose.\n10. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.\n11. Adequate washout period of previous therapy before the first dose.\n\nExclusion Criteria:\n\n1. Complicated with other malignant tumors within 3 years before the first dose.\n2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.\n3. Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.\n4. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.\n5. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:\n6. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n7. Uncontrolled infection.\n8. Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.\n9. Toxicity of previous anti-tumor treatment has not fully or partially recovered.\n10. Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.\n11. Pregnant and\u002For lactating women, or planning to become pregnant during the study period.\n12. Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.","ALL","18 Years","75 Years",{"count":20,"type":21},199,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.",[27],"Advanced Malignant Solid Tumors",[29,30],"EGFR\u002FHER3","JSKN021","NOT_YET_RECRUITING","2026-05-29",{"date":34,"type":35},"2026-06-01","ACTUAL",{"date":37,"type":21},"2026-05-31",{"date":39,"type":21},"2029-05-31",{"name":41,"class":42},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100633933","phase-3-a-phase-iii-study-of-jskn016-versus-treatment-of-physicians-choice-in-patients-with-triple-negative-breast-cancer-who-have-failed-standard-of-care-100633933","NCT07533123","A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care","A Randomized, Controlled, Open-Label Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Triple-Negative Breast Cancer Who Have Failed at Least Two Lines of Prior Systemic Therapy","Inclusion Criteria:\n\n* Voluntarily sign the Informed Consent Form (ICF).\n* Age ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 3 months.\n* Histologically and\u002For cytologically confirmed diagnosis of Triple-Negative Breast Cancer (TNBC) based on pathology reports from the most recent biopsy or other pathological specimens.\n* Failure of at least 2 prior lines of systemic chemotherapy.\n* At least one measurable extracranial lesion per Response Evaluation Criteria in Solid -Tumors (RECIST) v1.1.\n* Agree to provide a tumor tissue specimen.\n* Adequate organ and bone marrow function.\n* Recovery from prior treatment-related toxicities to ≤ Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, or as specified in the protocol for eligibility.\n* Assessed by the investigator as suitable to receive one of the following: eribulin, capecitabine, gemcitabine, vinorelbine, or sacituzumab govitecan.\n* Female participants of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days prior to randomization and agree to contraception during the trial.\n\nExclusion Criteria:\n\n* Prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC), with the exception of TROP2-targeted ADCs.\n* Diagnosis of another malignancy within 5 years prior to randomization, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma, cervical carcinoma in situ, and other carcinomas in situ.\n* Presence of cerebrovascular or cardiovascular diseases or risk factors.\n* Inadequate washout from prior therapies prior to randomization.\n* Presence of active central nervous system (CNS) metastases without prior local treatment; presence of metastases or compression of the brainstem, meninges, or spinal cord; or history of carcinomatous meningitis.\n* Presence of severe or uncontrolled concomitant diseases that may affect safety or compliance.\n* Tumor invasion of adjacent vital organs or blood vessels (such as the heart, esophagus, superior vena cava, etc.) or risk of developing an esophagotracheal fistula or esophagopleural fistula.\n* Active hepatitis B; active hepatitis C.\n* Positive test for human immunodeficiency virus (HIV) or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; known active tuberculosis infection.\n* History of allogeneic bone marrow or organ transplantation.\n* History of significant ophthalmic diseases.\n* History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment.",{"count":51,"type":21},364,[53],"PHASE3","Primary Endpoint of this Study:\n\nTo compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee \\[BIRC\\] based on Response Evaluation Criteria in Solid Tumors \\[RECIST v1.1\\]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC).\n\nTo compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.",[56],"Triple Negative Breast Cancer","RECRUITING","2026-04-14",{"date":60,"type":35},"2026-04-16",{"date":62,"type":21},"2026-03-17",{"date":64,"type":21},"2030-03-17",{"name":41,"class":42},1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":66},"100582855","phase-1-evaluation-of-jskn016-combination-therapy-in-subjects-with-nsclc-100582855","NCT06868732","Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC","Evaluation of JSKN016 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer: A Phase Ib Study","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form.\n2. Age ≥ 18 years old, ≤ 75 years old, male or female.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n4. Expected survival ≥ 3 months.\n5. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and\u002For radical radiotherapy.\n6. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.\n7. Recently archived or fresh tumor tissue samples are available.\n8. Have good organ function.\n9. Have no current birth plans and agree to contraception during the trial.\n\nExclusion Criteria:\n\n1. Presence of any small cell carcinoma component in histopathology.\n2. Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, and prostate\u002Fcervical\u002Fbreast cancer in situ.\n3. Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.\n4. During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula.\n5. Adequate washout of previous therapy before the first dose.\n6. Gastrointestinal abnormalities with obvious clinical manifestations.\n7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.\n8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n9. Prior treatment with topoisomerase I inhibitors (e.g., irinotecan, topotecan), antibody-drug conjugates containing topoisomerase I inhibitors (e.g., DS-8201, HER3-DXd, DS-1062), or targeting TROP2 or HER3.\n10. Previous treatment with docetaxel.\n11. Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS.\n12. Previous history of allogeneic bone marrow or organ transplantation.\n13. Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs.\n14. Pregnant and\u002For lactating females.\n15. Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and\u002For uncertainty in survival evaluation, such as tumor leukemia response , cachexia manifestations, etc.",{"count":75,"type":21},288,[24],"This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.",[79],"Advanced Non-small Cell Lung Cancer","2026-03-25",{"date":82,"type":35},"2026-03-30",{"date":84,"type":35},"2025-04-02",{"date":86,"type":21},"2028-12-30",{"name":41,"class":42},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100631161","phase-2-jskn033-combination-therapy-in-subjects-with-advanced-cervical-cancer-100631161","NCT07497074","JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer","A Phase II Study to Evaluate the Safety, Efficacy, Pharmacokinetics\u002FPharmacodynamics of JSKN033 in Combination With Platinum-Based Chemotherapy With or Without Bevacizumab in Patients With Advanced Cervical Cancer","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form.\n2. Age ≥ 18 years old, male or female.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n4. Expected survival ≥ 3 months.\n5. Histologically or cytologically confirmed persistent, recurrent, or metastatic (FIGO stage IVB) cervical cancer unsuitable for curative surgery and\u002For curative radiotherapy, meeting the following criteria:\n\n   1. Pathological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;\n   2. No prior systemic therapy for recurrent or metastatic cervical cancer.\n6. At least one measurable lesion per RECIST 1.1 at baseline.\n7. Agree to provide recently archived or fresh tumor tissue samples.\n8. Adequate organ function.\n9. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures. Female subjects of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days before the first dose.\n10. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.\n\nExclusion Criteria:\n\n1. Complicated with other malignant tumors within 3 years before the first dose, except for tumor types that have achieved clinical cure through local treatment with extremely low recurrence risk.\n2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.\n3. Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula, except those judged by the investigator and medical monitor to not affect the patient's enrollment and administration.\n4. Prior treatment with topoisomerase I inhibitors or antibody-drug conjugates containing topoisomerase I inhibitors.\n5. Inadequate washout period of previous therapy.\n6. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:\n7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.\n8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n9. Gastrointestinal abnormalities with obvious clinical manifestations.\n10. Significant serous effusion.\n11. Active autoimmune diseases requiring systemic treatment.\n12. Uncontrolled infection.\n13. Toxicity of previous anti-tumor treatment has not fully or partially recovered.\n14. History of allogeneic bone marrow or organ transplantation.\n15. Known allergy to any component of the study drug\u002Fplatinum, or history of severe allergic reactions to other antibody drugs.\n16. Pregnant and\u002For lactating women, or planning to become pregnant during the study period.\n17. Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.\n18. Any other previous or current diseases, treatments, or laboratory test abnormalities that the investigator deems may confuse the study results, affect the patient's full participation in the study, or participation in the study may not be in the best interest of the patient.\n19. Local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to high medical risks and\u002For uncertainty in survival assessment, such as tumor-related leukemia reaction (white blood cell count \\> 20×10⁹\u002FL), cachexia manifestations, etc.\n20. Known contraindications to bevacizumab or allergy to its components, or the medical conditions affecting its safe use (Note: Applicable only to subjects planned to receive bevacizumab).",{"count":96,"type":21},78,[98],"PHASE2","The goal of this clinical trial is to learn if the therapy of JSKN033 plus chemotherapy with or with bevacizumab is safe to treat patients with advanced cervical cancer. It will also learn about the antitumor activity and pharmacokinetic\u002F pharmacodynamic profiles of this therapy.",[101],"Cervical Cancer",[103,104,105],"JSKN033","PD-L1","Antibody-Drug Conjugates","2026-03-23",{"date":108,"type":35},"2026-03-27",{"date":110,"type":21},"2026-04",{"date":112,"type":21},"2028-06",{"name":41,"class":42},2,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":66},"100629506","phase-1-jskn016hc-in-patients-with-advanced-or-metastatic-solid-malignant-tumors-100629506","NCT07475559","JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics\u002F Pharmacodynamics, and Anti-tumor Activity of JSKN016HC in Subjects With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Patients who are able to understand the informed consent form (ICF), voluntarily participate, and sign the ICF;\n2. Patients who are ≥18 years of age on the day of signing the informed consent form, male or female;\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1;\n4. Life expectancy ≥ 3 months;\n5. At least one non-cranial measurable lesion at baseline according to RECIST 1.1 criteria. Target lesions must not have received prior local therapy (e.g., radiotherapy), or there must be evidence of disease progression in the lesion after local therapy;\n6. Patients with histologically and\u002For cytologically confirmed advanced unresectable or metastatic epithelial-derived malignant tumors who have failed prior standard of care (disease progression, intolerance, or inaccessibility of standard of case);\n7. Adequate organ function (results from within 7 days before the first dose are required for the following laboratory tests; echocardiogram results from within 28 days before the first dose are acceptable):\n\n   1. Bone marrow function (no whole blood or blood component transfusions within 14 days before the first dose; no use of haematopoietic growth factors within 7 days before the first dose): Absolute neutrophil count ≥1.5×109\u002FL; haemoglobin ≥90 g\u002FL; platelet count ≥100×109\u002FL;\n   2. Liver function (based on the normal values of each clinical study site): Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3×ULN (≤ 5×ULN for subjects with metastases to liver); albumin ≥ 28 g\u002FL;\n   3. Renal function: Blood creatinine ≤ 1.5 ×ULN, or creatinine clearance (Ccr) ≥ 60 mL\u002Fmin as calculated by the Cockcroft-Gault formula; urine protein ≤ 1+ or 24-hour (h) quantitative urine protein \\\u003C 1.0 g;\n   4. Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n   5. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% (by echocardiogram);\n8. Female patients of childbearing potential or male patients with partners of childbearing potential must agree to use highly effective contraception from the time of signing the ICF until 24 weeks after the last dose. Female patients of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days before the first dose;\n9. Patients who are able and willing to comply with the visits, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Presence of metastasis to brainstem, metastasis to meninges, metastasis to spinal cord or compression, or a history of carcinomatous meningitis; presence of active brain metastasis. Note: a. For patients with brain metastasis previously treated with local therapy (e.g., surgery, radiotherapy): patients who are clinically stable for at least 4 weeks before the first dose (imaging examination shows stable lesions, no new neurological symptoms, no evidence of new or enlarging pre-existing brain metastasis), and have not required corticosteroids or anticonvulsants for at least 2 weeks are eligible for enrollment; b. For patients with brain metastasis not previously treated with local therapy: patients with no neurological symptoms related to brain metastasis, not requiring corticosteroid treatment, no significant oedema around brain metastasis, and with all brain metastases \\\u003C 1.5 cm are eligible for enrollment;\n2. Imaging during the screening period shows the tumor invades or compresses the surrounding vital organs (e.g., heart and pericardium, trachea, oesophagus, superior vena cava, etc.) or risk of developing oesophageal-tracheal fistula or oesophageal-pleural fistula;\n3. Insufficient washout period for prior therapies before the first dose:\n\n   1. Receipt of any investigational drug within 28 days before dosing;\n   2. Receipt of other anti-tumor therapy within 28 days before dosing or within 5 half-lives of a prior anti-tumor drug (whichever is shorter, but at least 14 days is required);\n   3. Receipt of Chinese herbal medicines or proprietary Chinese medicines with a clear anti-tumor indication within 14 days before dosing;\n   4. Receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 14 days before the first dose;\n   5. Requirement for continuous treatment with glucocorticoids (\\> 10 mg\u002Fday prednisone, or equivalent dose of other glucocorticoids) or immunosuppressants for 7 days within 14 days before the first dose; excluding inhaled or topical steroids, or physiological replacement doses of steroids for adrenal insufficiency; short-term (≤7 days) use of glucocorticoids for prophylaxis (e.g., for contrast media allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity due to allergen exposure) is permitted;\n   6. Receipt of local palliative therapy within 14 days before dosing;\n   7. Major surgery within 28 days before dosing (e.g., major abdominal or thoracic surgery; minor procedures such as diagnostic aspiration, infusion device implantation, or biliary stent placement are not included), or anticipation of requiring major surgery during the study;\n   8. Receipt of a live vaccine within 30 days before the first dose, or planned receipt of a live vaccine during the study;\n4. Prior treatment with an ADC containing a topoisomerase I inhibitor (e.g., DS-8201, HER3-DXd, DS-1062, etc);\n5. Concurrent other malignant tumor within 5 years before dosing, excluding cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, and in situ prostate\u002Fcervical\u002Fbreast cancer\u002F papillary thyroid carcinoma, etc;\n6. Presence or history of the following lung disorders that cause severe impairment of respiratory function:\n\n   1. Active or severe structural lung disorder: including pulmonary embolism diagnosed within 6 months before the first dose, uncontrolled severe asthma (e.g., requiring continuous systemic steroid therapy or frequent acute exacerbations), severe chronic obstructive pulmonary disease, or severe restrictive pulmonary disease (e.g., severe pulmonary fibrosis, deformity thorax), etc.;\n   2. Systemic diseases with pulmonary involvement: autoimmune diseases, connective tissue diseases, or inflammatory diseases (e.g., rheumatoid arthritis, sicca syndrome, sarcoidosis, etc.) causing significant impairment of respiratory function;\n   3. Pulmonary resection: prior pneumonectomy;\n7. Current interstitial lung disease (ILD) or non-infectious pneumonia (e.g., idiopathic pulmonary fibrosis, radiation pneumonitis, etc.) requiring systemic glucocorticoid or other immunosuppressant therapy;\n8. Clinically significant gastrointestinal abnormalities, including but not limited to:\n\n   1. Intestinal obstruction or signs and symptoms of intestinal obstruction within 6 months before the first dose, but screening is permissible if surgery has been performed and the obstruction is completely resolved (patients who have previously received an intestinal stent that has not been removed by the screening period are not allowed to enroll);\n   2. History of gastrointestinal perforation, intestinal fistula, intra-abdominal abscess, and non-gastrointestinal fistula (e.g., oesophageal-tracheal fistula) within 6 months before the first dose;\n   3. Gastrointestinal haemorrhage of ≥ Grade 3 (CTCAE v5.0) within 6 months before the first dose, or gastrointestinal haemorrhage within 1 month (including melaena, haematochezia, etc.; patients confirmed to have haemorrhoidal haemorrhage or only presenting with faecal occult blood positive are eligible for enrollment);\n9. Active autoimmune disease requiring systemic treatment within the past two years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants). Note: Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment;\n10. Presence of serous cavity effusion (e.g., pleural effusion, pericardial effusion, ascites) that is clinically symptomatic or requires repeated drainage(\\>1 time\u002Fweek), or has required drainage within 14 days before the first dose;\n11. Presence of any of the following cardiovascular or cerebrovascular disorders or risk factors:\n\n    1. Myocardial infarction, unstable angina, acute or persistent myocardial ischaemia, Grade ≥3 cardiac failure (NYHA classification), symptomatic or poorly controlled severe arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, complete left or right bundle branch block, history of second- or third-degree heart block, etc.), cerebrovascular accident, transient ischaemic attack, or other severe cardiovascular or cerebrovascular disorders within 6 months before the first dose;\n    2. Any arterial thromboembolic event or venous thromboembolic event of ≥ Grade 3 (CTCAE v5.0) within 6 months before the first dose;\n    3. Presence of major vascular diseases that may be life-threatening or require surgery within 6 months, such as aortic aneurysm, aortic dissection, or severe internal carotid artery stenosis;\n    4. Risk of QT interval prolongation or severe arrhythmia, including baseline QT interval corrected by Fridericia's formula (QTcF) \\> 470 ms, refractory hypokalaemia, long QT syndrome, etc.;\n    5. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n    6. Presence of moderate to severe pulmonary arterial hypertension;\n12. Uncontrolled infection, including but not limited to the following:\n\n    1. Active HBV or HCV infection. HBsAg-positive patients are required to undergo HBV-DNA testing; if HBV-DNA is above the lower limit of detection of the local laboratory, they will be excluded. For HBsAg-positive patients, enrollment is permitted if HBV-DNA is below the lower limit of detection after receiving antiviral therapy, and anti-HBV therapy should be continued after subsequent treatment. HCV-Ab-positive patients are eligible for enrollment if HCV-RNA test is negative;\n    2. Severe infection within 4 weeks before the first dose, including but not limited to comorbidities requiring hospitalisation, sepsis, or severe pneumonia; active infection requiring systemic anti-infective drug therapy within 2 weeks before the first dose;\n    3. History of immunodeficiency, positive test for human immunodeficiency virus (HIV), or history of acquired immunodeficiency syndrome (AIDS);\n    4. Known active tuberculosis;\n    5. Active syphilis;\n13. Toxicity from prior anti-tumor therapy has not resolved to ≤ Grade 1 (CTCAE v5.0) or the level specified in the inclusion\u002Fexclusion criteria. Note: Patients with chronic, stable Grade 2 toxicity that the investigator considers related to prior anti-tumor therapy may be enrolled after discussion with the sponsor and medical monitor (defined as stable toxicity severity, CTCAE Grade ≤2, within 3 months before the first dose), such as: chemotherapy-induced neurotoxicity, alopecia, skin hyperpigmentation, fatigue, endocrine toxicity from prior immunotherapy (e.g., thyroid dysfunction, diabetes mellitus, adrenal insufficiency);\n14. History of prior allogeneic bone marrow or organ transplant;\n15. Known hypersensitivity to any component of the investigational product; history of severe allergic reactions to other antibody-based drugs;\n16. History of severe xerophthalmia, severe meibomian gland disease and\u002For blepharitis, keratopathy causing incurable or delayed healing of the subject's cornea, or maculopathy;\n17. Women who are pregnant and\u002For breastfeeding, or who plan to become pregnant during the study;\n18. Known history of psychiatric illness, drug abuse, alcoholism, etc., or other conditions that, in the investigator's opinion, would interfere with the safety or compliance of drug therapy in this study;\n19. Prior or current presence of any other disease, treatment, or abnormal laboratory test that might confound the study results, interfere with the subject's full participation in the study, or for which participation in the study might not be in the subject's best interest;\n20. Presence of local or systemic diseases caused by non-malignant tumor, or diseases or symptoms secondary to the tumor, which may lead to higher medical risk and\u002For uncertainty in survival assessment, such as tumor-related leukaemoid reaction (white blood cell count \\>20×109\u002FL), cachexia, etc.",{"count":123,"type":21},42,[24],"This is a Phase I, open-label, multicenter, first-in-human study to evaluate the safety, tolerability, PK\u002Fpharmacodynamic (PD) characteristics, and anti-tumor activity of JSKN016HC in subjects with advanced malignant solid tumors.",[127],"Advanced Solid Tumor Malignancies","2026-03-11",{"date":130,"type":35},"2026-03-16",{"date":132,"type":21},"2026-03-01",{"date":134,"type":21},"2028-07-01",{"name":41,"class":42},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":66},"100623054","phase-1-a-study-of-jskn027-in-patients-with-advanced-solid-tumors-100623054","NCT07391644","A Study of JSKN027 in Patients With Advanced Solid Tumors","A First-in-Human, Open-Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of JSKN027 in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of signing the ICF.\n* ECOG performance status 0-1.\n* Estimated life expectancy ≥ 3 months.\n* Histologically or cytologically confirmed advanced or metastatic malignant solid tumor.\n* For dose escalation (Part Ia): disease has progressed on standard therapy.\n* For dose expansion (Part Ib): participants with prespecified tumor types (e.g., colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and other selected solid tumors) who have progressed on standard therapy.\n* At least one measurable extracranial lesion per RECIST v1.1.\n* Adequate bone marrow function within 7 days prior to enrollment (e.g., ANC ≥ 1.5×10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100×10\\^9\u002FL).\n* Adequate hepatic function within 7 days prior to enrollment (e.g., total bilirubin, AST\u002FALT, ALP within protocol-defined limits; albumin ≥ 30 g\u002FL).\n* Adequate renal function within 7 days prior to enrollment (e.g., serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL\u002Fmin; urine protein within acceptable limits).\n* Adequate coagulation function within 7 days prior to enrollment (e.g., PT\u002FINR and aPTT within protocol-defined limits).\n* Adequate cardiac function (e.g., LVEF ≥ 50%).\n* Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n* Participants of reproductive potential agree to use highly effective contraception from ICF signing until 7 months after the last dose.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease (e.g., active brain metastases or leptomeningeal disease).\n* Received an investigational agent within 28 days or 5 half-lives (whichever is shorter) prior to first dose.\n* Major surgery within 28 days prior to first dose or planned major surgery during the study.\n* History of severe immune-related adverse events or prior toxicity that would preclude safe participation, as judged by the investigator.\n* Significant gastrointestinal disorders that increase risk of perforation, bleeding, obstruction, or interfere with study participation.\n* Active or uncontrolled interstitial lung disease (ILD) or non-infectious pneumonitis, or suspected ILD\u002Fpneumonitis at screening.\n* Active autoimmune disease requiring systemic immunosuppression (exceptions may apply for limited, stable conditions).\n* Active hepatitis B or C, HIV infection, or other clinically significant immunodeficiency\u002Finfection not adequately controlled per local standards.\n* Prior allogeneic organ or bone marrow transplant.\n* Known hypersensitivity to the study drug or its excipients, or history of severe hypersensitivity to similar biologic agents.\n* Pregnant or breastfeeding.\n* Any condition that, in the investigator's judgment, would compromise participant safety or compliance.",{"count":144,"type":21},250,[24],"This is a first-in-human, open-label, multicenter Phase 1 (Ia\u002FIb) clinical study conducted in China to evaluate the safety and tolerability of JSKN027 in patients with advanced malignant solid tumors. The study will also assess the pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of JSKN027, and determine the maximum tolerated dose (MTD) and\u002For the recommended Phase 2 dose (RP2D).\n\nThe study includes two parts. Part Ia is a dose-escalation phase designed to evaluate the safety and tolerability of increasing dose levels of JSKN027. Part Ib is a dose-expansion phase in which additional patients will be enrolled at selected dose levels to further evaluate safety and preliminary antitumor activity in specific tumor types. Initial expansion cohorts are planned for patients with colorectal cancer, non-small cell lung cancer, and hepatocellular carcinoma.",[148],"Advanced Malignant Solid Tumor","2026-01-30",{"date":151,"type":35},"2026-02-06",{"date":153,"type":21},"2026-03-15",{"date":155,"type":21},"2029-06-30",{"name":41,"class":42},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":177,"locationsCount":66},"100618834","phase-1-jskn016-in-combination-with-d-0502-for-locally-advanced-or-metastatic-hr-positive-her2-negative-breast-cancer-100618834","NCT07336771","JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer","A Multicenter, Open-Label, Phase Ib\u002FII Randomized Study of JSKN016 in Combination With D-0502 in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically or cytologically confirmed locally advanced or metastatic HR-positive, HER2-negative breast cancer\n* HR-positive defined as ER and\u002For PR ≥1% by IHC\n* HER2-negative per ASCO\u002FCAP guidelines\n* At least one measurable extracranial lesion per RECIST v1.1\n* ECOG performance status 0-1\n* Prior progression on CDK4\u002F6 inhibitor plus endocrine therapy\n* Adequate organ and cardiac function\n* Postmenopausal women, or premenopausal women receiving ovarian function suppression\n\nExclusion Criteria:\n\n* Active or untreated CNS metastases\n* Prior treatment with ADCs containing topoisomerase I inhibitor payloads\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled cardiovascular disease or active infection\n* Prior malignancy within 5 years (with specific exceptions)\n* Pregnancy or breastfeeding",{"count":165,"type":21},60,[24,98],"This is a multicenter, open-label, Phase Ib\u002FII randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective estrogen receptor degrader (SERD) D-0502 in patients with locally advanced or metastatic hormone receptor-positive (HR+), HER2-negative breast cancer who have previously progressed on CDK4\u002F6 inhibitor-based endocrine therapy.\n\nApproximately 60 patients will be randomized in a 1:1 ratio to receive JSKN016 administered intravenously every 2 weeks (Q2W) or every 3 weeks (Q3W), in combination with daily oral D-0502. Each dosing cohort will include a safety lead-in phase to assess DLTs prior to cohort expansion. Tumor response will be assessed according to RECIST v1.1.",[169,170],"Metastatic Breast Cancer","Locally Advanced Breast Cancer (LABC)","2026-01-04",{"date":173,"type":35},"2026-01-13",{"date":175,"type":21},"2026-01",{"date":112,"type":21},{"name":41,"class":42},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":66},"100615422","phase-1-jskn022-in-subjects-with-advanced-malignant-solid-tumors-100615422","NCT07292402","JSKN022 in Subjects With Advanced Malignant Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics, and Antitumor Activity of JSKN022 in Subjects With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form.\n2. Age ≥ 18 years old, male or female.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n4. Expected survival ≥ 3 months.\n5. Histologically or cytologically confirmed malignant solid tumors confirmed by histology and\u002For cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.\n6. At least one measurable lesion at baseline according to RECIST 1.1 criteria.\n7. Adequate organ function.\n8. Agree to provide Recently archived or fresh tumor tissue samples.\n9. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.\n10. Female subjects of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days before the first dose.\n11. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.\n12. Adequate washout period of previous therapy before the first dose.\n\nExclusion Criteria:\n\n1. Complicated with other malignant tumors within 5 years before the first dose, except for tumor types that have achieved clinical cure through local treatment with extremely low recurrence risk or tumor types with disease-free survival ≥ 5 years after radical treatment and extremely low recurrence\u002Fmetastasis risk.\n2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.\n3. Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula, except those judged by the investigator and medical monitor to not affect the patient's enrollment and administration.\n4. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.\n5. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:\n6. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n7. Gastrointestinal abnormalities with obvious clinical manifestations.\n8. Active autoimmune diseases requiring systemic treatment within the past two years.\n9. Significant serous effusion.\n10. Uncontrolled infection.\n11. Require regular glucocorticoid or immunosuppressive therapy.\n12. Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.\n13. Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors.\n14. Previous occurrence of grade ≥ 3 immune-related adverse events during immunotherapy.\n15. Toxicity of previous anti-tumor treatment has not fully or partially recovered.\n16. Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.\n17. Pregnant and\u002For lactating women, or planning to become pregnant during the study period.\n18. Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.\n19. Local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to high medical risks and\u002For uncertainty in survival assessment, such as tumor-related leukemia reaction (white blood cell count \\> 20×10⁹\u002FL), cachexia manifestations, etc.\n20. Any other previous or current diseases, treatments, or laboratory test abnormalities that the investigator deems may confuse the study results, affect the patient's full participation in the study, or participation in the study may not be in the best interest of the patient.",{"count":186,"type":21},225,[24],"The goal of this clinical trial is to learn if drug JSKN022 is safe to treat patients with advanced malignant solid tumors. It will also learn about the pharmacokinetic\u002F pharmacodynamic profiles and preliminary antitumor activity of drug JSKN022.",[27],[191,104,192,105],"JSKN022","ITGB6","2025-12-17",{"date":195,"type":35},"2025-12-23",{"date":197,"type":35},"2025-10-23",{"date":199,"type":21},"2027-12-31",{"name":41,"class":42},{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":4},"100614715","phase-2-a-phase-ii-clinical-study-to-evaluate-the-safety-efficacy-pharmacokineticspharmacodynamics-of-jskn033-in-patients-with-advanced-non-small-cell-lung-cancer-100614715","NCT07283198","A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics\u002FPharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Subjects can understand the informed consent form,voluntarily participate in the study, and sign the informed consent form.\n2. Subjects are≥18 years old on the day of signing the informed consent form, regardless of gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n4. Expected survival time ≥3 months.\n5. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (per AJCC 8th Edition Lung Cancer TNM Staging) that is not eligible for curative surgery and\u002For curative radiotherapy.\n6. NSCLC confirmed to be no other known driver gene alterations for which first- line targeted therapy has been approved.\n7. For Part 1(Dose Selection): Enrolled subjects are those with advanced unresectable or metastatic NSCLC who have failed or are intolerant to standard previous treatments, and have HER2 mutation or HER2 expression in tumor tissue.\n8. For Part 2 (Cohort Expansion): Enrolled subjects are those with locally advanced or metastatic NSCLC who have not received prior systemic anti-tumor treatment for their advanced disease.\n9. Per RECIST 1.1 criteria,subjects have at least one extracranial measurable lesion at baseline.\n10. Subjects must provide tumor tissue samples.\n11. Sufficient organ function.\n12. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use highly effective contraceptive measures from the time of signing the informed consent form until 24 weeks after the last dose.\n\nExclusion Criteria:\n\n1. Presence of any small cell carcinoma component in the histological pathology.\n2. History of other malignant tumors within 5 years prior to the first dose administration.\n3. History of brainstem, meningeal, or spinal cord metastases\u002Fcompression, or carcinomatous meningitis; presence of active brain metastases.\n4. Imaging during the screening phase shows tumor invasion, compression, or location in surrounding vital organs.\n5. Sufficient washout period from previous treatments prior to the first dose.\n6. Presence of the following lung diseases or medical history leading to severe respiratory impairment.\n7. Presence of risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia.\n8. Presence of cardiovascular and cerebrovascular diseases or risk factors.\n9. Presence of uncontrolled infections.\n10. Toxicity from previous anti-tumor treatment has not recovered to grade≤1 (per CTCAE v5.0).\n11. Previous history of allogeneic bone marrow or organ transplantation.\n12. Known allergy to any component of the study drug.\n13. Pregnant and\u002For lactating women, or women planning to become pregnant during the study.",{"count":208,"type":21},160,[98],"This is an open-label, multicenter, Phase II clinical study designed to evaluate the safety and efficacy of JSKN033 in the treatment of patients with advanced NSCLC. The study is divided into two phases: Part 1 (Dose Selection) and Part 2 (Cohort Expansion). Enrolled subjects are patients with locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) NSCLC who are not eligible for curative treatment. Part 1 (Dose Selection): It consists of two dose groups, with a maximum of 20 subjects enrolled in each group. Part 2 (Cohort Expansion): It consists of two cohorts, with a maximum of 60 subjects enrolled in each cohort.",[212],"Non Small Cell Lung Cancer (NSCLC)","2025-12-02",{"date":215,"type":35},"2025-12-15",{"date":217,"type":21},"2025-12-10",{"date":219,"type":21},"2027-08-30",{"name":41,"class":42},{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":241,"locationsCount":66},"100588502","phase-1-study-of-jskn016-combination-therapy-in-inoperable-locally-advanced-or-metastatic-her2-negative-breast-cancer-100588502","NCT06942234","Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer","The Multicenter, Open-label, Single-arm, Multi-cohort Phase Ib\u002FII Clinical Study to Evaluate the Efficacy and Safety of JSKN016 in Combination Therapy in Chinese Participants With Inoperable Locally Advanced or Metastatic HER2-negative Breast Cancer","Inclusion Criteria:\n\n1. Capable of understanding and signing the informed consent form.\n2. Aged ≥18 and ≤75 years, regardless of sex.\n3. Histologically or cytologically confirmed inoperable locally advanced or metastatic HER2-negative breast cancer.\n4. Hormone receptor-positive participants with progression\u002Fintolerance after standard endocrine therapy, or unsuitable for it.\n5. Disease progression confirmed by radiological evidence post-systemic treatment.\n6. Available archived or newly obtained tumor tissue\u002Fbiopsy.\n7. No prior systemic therapy for advanced disease, except for prior endocrine ± targeted therapy or CDK4\u002F6 inhibitors.\n8. Measurable non-CNS lesion per RECIST 1.1.\n9. Expected survival ≥3 months.\n10. ECOG performance status of 0 or 1.\n11. Contraceptive use agreement for fertile participants.\n12. Adequate organ function within 7 days of enrollment:\n\n    * Bone marrow: ANC ≥1.5 × 10⁹\u002FL, Hemoglobin ≥90 g\u002FL, Platelets ≥100 × 10⁹\u002FL.\n    * Liver: Bilirubin ≤1.5 × ULN, ALT\u002FAST ≤3 × ULN.\n    * Renal: Creatinine ≤1.5 × ULN or Ccr ≥60 mL\u002Fmin.\n    * Coagulation: INR\u002FPT ≤1.5 × ULN, APTT ≤1.5 × ULN.\n13. LVEF ≥50%.\n\nExclusion Criteria:\n\n1. CNS metastasis (except stable cases treated with radiation or surgery).\n2. Unstable spinal cord compression or untreated history.\n3. Recent live vaccine (except seasonal flu vaccines).\n4. Recent anti-tumor treatment within 28 days or 5 half-lives (whichever is shorter).\n5. Recent palliative therapy within 14 days.\n6. Major surgery within 28 days or planned during the study.\n7. Severe gastrointestinal issues or recent major GI bleeding.\n8. Uncontrolled pleural\u002Fperitoneal effusions or cachexia.\n9. Prior HER3\u002FTROP2-targeted therapy or topoisomerase I inhibitors.\n10. Other malignancies within 5 years (except certain skin or localized cancers).\n11. Current interstitial lung disease or uncontrolled infections.\n12. Severe hypercalcemia or uncontrolled cancer-related pain.\n13. Autoimmune diseases, unless stable with treatment.\n14. Uncontrolled comorbidities (e.g., active infections, cardiovascular issues).\n15. Toxicities from previous treatments not resolved to CTCAE ≤1.\n16. Recent steroid use or need for systemic immunosuppressive therapy.\n17. Allergy to study drug components.\n18. Pregnancy or breastfeeding.",{"count":229,"type":21},180,[24,98],"This study aims to evaluate the safety and effectiveness of JSKN016 in combination with different treatments for patients with HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body. The study includes four groups of patients based on treatment history and tumor characteristics. Each group will receive JSKN016 with chemotherapy or immunotherapy. The goal is to find out how well the treatment works and how safe it is.",[233,234],"Inoperable Locally Advanced HER2-Negative Breast Cancer","Metastatic HER2-Negative Breast Cancer","2025-09-11",{"date":237,"type":35},"2025-09-17",{"date":239,"type":35},"2025-06-01",{"date":199,"type":21},{"name":41,"class":42},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},"100522235","phase-3-jskn003-versus-treatment-of-physicians-choice-for-her2-low-unresectable-andor-metastatic-breast-cancer-subjects-100522235","NCT06079983","JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and\u002For Metastatic Breast Cancer Subjects","A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and\u002For Metastatic Breast Cancer Subjects","Inclusion Criteria:\n\n* 1\\. The subject is able to understand the informed consent form, voluntarily participate and sign the informed consent form.\n\n  2\\. The subject ≥ 18 years old on the day of signing the informed consent form, male or female.\n\n  3\\. Unresectable locally recurrent or metastatic breast cancer, previous histopathological reports of HER2 IHC 1+ or 2+ and ISH-, previous histopathological reports have not been diagnosed as HER2 IHC 3+ or 2+ and ISH+.\n\n  4\\. Have received at least 1 to 2 lines of chemotherapy regimens for breast cancer in the relapse\u002Fmetastatic stage.\n\n  5\\. Willing to provide sufficient archived tumor pathology specimens for central laboratory detection of HER2 status.\n\n  6\\. Documented radiographic disease progression (during or after the most recent treatment).\n\n  7\\. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.\n\n  8\\. Expected survival ≥ 3 months. 9. ECOG score of 0 or 1 within 14 days prior to administration. 10. Female subjects of childbearing potential or male subjects of fertile partner consent to use highly effective contraception from the signing of informed consent.\n\n  11\\. Laboratory tests within 14 days before administration and cardiac function tests within 28 days meet the criteria.\n\n  12\\. Have sufficient elution of previous treatment before administration.\n\nExclusion Criteria:\n\n* 1\\. Untreated, or unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis.\n\n  2\\. Patients with only skin lesions as target lesions. 3. Those with a history of other primary malignant tumors within 5 years before administration.\n\n  4\\. Selection of the control drug by the investigator who is not suitable for the protocol prescribed.\n\n  5\\. Previous use of antibody conjugates containing topoisomerase I inhibitors. 6. There is a third gap fluid that cannot be controlled by drainage, etc. 7. Previous or current interstitial pneumonia\u002Flung disease requiring systemic hormone therapy.\n\n  8\\. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect oral administration and absorption of the drug.\n\n  9\\. Previous or current autoimmune disease. 10. Have uncontrolled comorbidities. 11. The toxicity of previous antitumor therapy has not been restored to grade ≤1 (NCI-CTCAE v5.0).\n\n  12\\. History of previous immunodeficiency. 13. History of life-threatening allergic reactions or known ≥ grade 3 allergy to any component or excipient in the investigational pharmaceutical formulation.\n\n  14\\. Other conditions that the investigators believe will affect the safety or adherence to drug treatment in this study, including but not limited to psychiatric disorders, alcohol or drug abuse.",{"count":250,"type":21},400,[53],"This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy.\n\nThe study planned to enroll 408 subjects in a 1:1 ratio and stratified block randomization method assigned to:\n\n* Experimental group: JSKN003 monotherapy\n* Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy",[254],"Breast Cancer","2025-09-08",{"date":257,"type":35},"2025-09-12",{"date":259,"type":35},"2023-12-01",{"date":261,"type":21},"2029-03-01",{"name":41,"class":42},87,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":4},"100575684","phase-2-evaluation-of-jskn016-in-the-treatment-of-advanced-non-small-cell-lung-cance-a-phase-ii-clinical-study-100575684","NCT06775483","Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form.\n2. Age ≥ 18 years old, male or female.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n4. Expected survival ≥ 3 months.\n5. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and\u002For radical radiotherapy, and meets one of the following conditions: EGFR sensitive mutations, and failed treatment with EGFR-TKI; Driver gene negative, treated with PD-1\u002FL1 inhibitors and a platinum-containing chemotherapy and treatment failure; Positive driver gene, failure of corresponding standard therapy;\n6. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.\n7. Recently archived or fresh tumor tissue samples are available.\n8. Have good organ function.\n9. Have no current birth plans and agree to contraception during the trial.\n\nExclusion Criteria:\n\n1. Presence of any small cell carcinoma component in histopathology.\n2. Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, and prostate\u002Fcervical\u002Fbreast cancer in situ.\n3. Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.\n4. During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula.\n5. Adequate washout of previous therapy before the first dose.\n6. Gastrointestinal abnormalities with obvious clinical manifestations.\n7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.\n8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n9. Prior treatment with topoisomerase I inhibitors (e.g., irinotecan, topotecan), antibody-drug conjugates containing topoisomerase I inhibitors (e.g., DS-8201, HER3-DXd, DS-1062), or targeting TROP2 or HER3.\n10. Previous treatment with docetaxel.\n11. Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS.\n12. Previous history of allogeneic bone marrow or organ transplantation.\n13. Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs.\n14. Pregnant and\u002For lactating females.\n15. Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and\u002For uncertainty in survival evaluation, such as tumor leukemia response , cachexia manifestations, etc.",{"count":271,"type":21},220,[98],"This is a Phase II clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.The study is divided into two parts. The main objective of part I is to assess the efficacy and safety of JSKN016 in selected subjects with advanced non-small cell lung cancer. The main objective of part II is to compare the efficacy of JSKN016 and docetaxel in subjects with advanced non-small cell lung cancer.",[79],"2025-01-13",{"date":277,"type":35},"2025-01-15",{"date":279,"type":21},"2025-01-17",{"date":281,"type":21},"2027-11-30",{"name":41,"class":42},{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":299,"leadSponsor":300,"locationsCount":4},"100575330","phase-1-jskn033-in-chinese-subjects-with-advanced-malignant-tumors-100575330","NCT06770881","JSKN033 in Chinese Subjects with Advanced Malignant Tumors","Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics, and Antitumor Activity of JSKN033 in Chinese Subjects with Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Be able to understand informed consent form, voluntarily participate and sign informed consent form.\n2. Age ≥18 year (at the time consent is obtained), male or female.\n3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Has a Life expectancy ≥3 months.\n5. Has a pathologically documented advanced\u002Funresectable or metastatic solid malignant tumor that is refractory to or intolerable with standard treatment.\n6. Has at least 1 measurable lesion at baseline according to RECIST 1.1 criteria.\n7. Must have adequate organ function prior to the start of JSKN033.\n8. Negative urine\u002Fserum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.\n\nExclusion Criteria:\n\n1. Has clinically active brain metastases.\n2. Previously received any other investigational drug within 28 days prior to enrollment.\n3. Previously received local palliative treatment within 14 days prior to enrollment.\n4. Previously received major surgeries within 28 days prior to enrollment.\n5. Need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment.\n6. Previously received live vaccine within 28 days prior to enrollment.\n7. Previously received antibody conjugate drug with topoisomerase I inhibitor.\n8. Has a history of other primary malignant tumors within 5 years prior to enrollment.\n9. Has uncontrolled comorbidities as specified by the protocol.\n10. Has a history of interstitial pneumonia\u002Flung disease requiring systemic hormonal therapy, or suspected interstitial pneumonia\u002Flung disease that cannot be ruled out by imaging during screening period.\n11. Subjects with uncontrolled large serous cavity effusion or moderate to large serous cavity effusion requiring repeated drainage (recurrent within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, etc.\n12. Toxicities of previous antitumor therapy did not resolve to grade 1 defined by CTCAE v5.0.\n13. Has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient to the study drug.\n14. Has a history of allogeneic bone marrow or organ transplantation.\n15. Pregnant or breastfeeding female patients.\n16. Other conditions that the investigator considers unsuitable to participate in this clinical trial, including but not limited to psychiatric disorders, alcoholism or drug abuse, etc.",{"count":291,"type":21},430,[24,98],"This is a phase I\u002FII multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced\u002Fmetastatic solid tumors.",[295],"Advanced Malignant Tumors","2025-01-07",{"date":275,"type":35},{"date":277,"type":21},{"date":199,"type":21},{"name":41,"class":42},{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":308,"minAge":17,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":310,"briefSummary":311,"conditions":312,"keywords":316,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":322,"leadSponsor":324,"locationsCount":4},"100573838","phase-3-jskn003-in-platinum-resistant-relapsed-epithelial-ovarian-cancer-100573838","NCT06751485","JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer","A Randomized, Open-Label, Parallel-Controlled, Multi-center Phase Ⅲ Study of JSKN003 Versus Investigator-Choice Chemotherapy for Platinum-Resistant, Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","Inclusion Criteria:\n\n* Voluntary participation and written informed consent.\n* ≥18 years;\n* Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.\n* Confirmed platinum-resistant relapse.\n* According to RECIST 1.1 criteria, there must be at least one measurable lesion in the baseline.\n* Expected survival of more than 3 months.\n* ECOG performance status score of 0 or 1.\n* Adequate organ function.\n* Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.\n\nExclusion Criteria:\n\n* Primary platinum-refractory disease.\n* Active central nervous system metastases.\n* Uncontrolled pleural effusion.\n* Previous treatment with topoisomerase I inhibitor ADCs.\n* Other malignant tumors within 5 years.\n* Interstitial pneumonia\u002Flung disease requiring systemic corticosteroids or suspected interstitial pneumonia\u002Flung disease.\n* Uncontrolled comorbidities.\n* Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1.\n* History of allogeneic bone marrow or organ transplantation.\n* Allergic reactions or hypersensitivity to antibody drugs.\n* Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.","FEMALE",{"count":291,"type":21},[53],"This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube cancer.",[313,314,315],"Ovarian Cancer","Primary Peritoneal","Fallopian Tube Cancers",[317],"JSKN003-306","2024-12-27",{"date":320,"type":35},"2024-12-31",{"date":277,"type":21},{"date":323,"type":21},"2027-12-30",{"name":41,"class":42},{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":333,"briefSummary":334,"conditions":335,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":114},"100561611","phase-1-to-evaluate-the-phase-i-clinical-study-of-jskn016-in-chinese-patients-with-advanced-malignant-solid-tumors-100561611","NCT06592417","To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* 1\\. Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form; 2. The subjects were ≥18 years old on the day of signing the informed consent, male or female; 3. Subjects with histologically and\u002For cytologically confirmed advanced unresectable or metastatic epithelial malignancies that have failed or are intolerable to previous standard therapies, preferentially but not limited to the following types: AGA-positive non-small cell lung cancer, HER2 IHC 0 breast cancer, etc.\n\n  4\\. For AGA-positive NSCLC, the presence of at least one of the following mutations is required; EGFR, ALK, ROS1, NTRK, BRAF V600, MET exon 14, RET, KRAS G12C, or HER2;\n  * For the enrolled subjects, the above driver gene mutations were not tested, but the previous test results confirmed by the investigators were accepted;\n  * If only EGFR overexpression without driver gene mutation can not be included;\n  * Prior osimertinib therapy is required if EGFR T790M mutation is present;\n  * Participants had to have failed at least one prior targeted therapy and at least platinum-based chemotherapy with or without an immune checkpoint inhibitor or antiangiogenic agent; 5. Breast cancer patients with HER2 IHC 0 expression, regardless of hormone receptor (HR) expression, could be enrolled according to the results of IHC examination in our center.\n\n    6\\. At least one measurable lesion at baseline according to RECIST 1.1 criteria. Measurable disease required either no previous local treatment (e.g., radiotherapy) or evidence of disease progression after local treatment.\n\n    7\\. Expected survival time ≥3 months; 8. ECOG score 0 or 1; 9. Female subjects of childbearing potential or male subjects with a fertile partner agreed to use highly effective contraception from the time they provided written informed consent until 24 weeks after the last dose. Female subjects of childbearing potential had to have a negative serum\u002Furine pregnancy test within 7 days before randomization (for women of childbearing age, see Appendix 2).\n\n    10\\. Adequate organ function within 7 days before randomization:\n  * Bone marrow function: absolute neutrophil count ≥1.5×109\u002FL; Hemoglobin ≥90 g\u002FL; Platelet count ≥100×109\u002FL (no whole blood or blood component transfusion within 14 days before randomization; No administration of hematopoietic cytokines within 7 days before randomization).\n  * Liver function (based on the normal value of each clinical research center) : total bilirubin \\\u003C 1.5 times the upper limit of normal value (ULN, total bilirubin in subjects with liver metastasis ≤3 x ULN); ALT\u002FAST≤3×ULN (≤5×ULN in patients with liver metastasis); Albumin ≥28g\u002FL; Renal function: serum creatinine ≤1.5 times the upper limit of normal, or creatinine clearance (Ccr) calculated according to Cockcroft-Gault formula (see Appendix 4) ≥ 60 mL\u002Fmin; Coagulation function: INR or PT≤ 1.5x ULN, and aPTT≤ 1.5x ULN (low stable dose of anticoagulant, such as aspirin 100 mg\u002F day is allowed); 11. Left ventricular ejection fraction (LVEF) ≥50% (by echocardiography \\[ECHO\\]); 12. Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\n* 1\\. Patients with symptoms of active central nervous system metastases, except those with stable parenchymal brain metastases as assessed by investigators, were defined as seizure-free for more than 12 weeks with or without the use of antiepileptic drugs; No need for glucocorticoids; At least one MRI showed that the patient was stable on imaging. Or stable after treatment for more than 1 month without symptoms; 2. Received any investigational drug within 28 days before dosing; 3. Receipt of other antineoplastic therapy within 28 days before dose or within 5 half-lives of previous antineoplastic drugs, whichever is shorter but requires a minimum of 14 days; Received Chinese herbal medicine with clear anti-tumor indications within 14 days before drug administration; 4. Local palliative treatment within 14 days before administration; 5. Major surgical treatment (such as transabdominal or transthoracic surgery) within 28 days before drug administration; Excluding minor procedures such as diagnostic punctures or infusion device implantation or biliary stenting) or anticipated need for major surgical treatment during the study period; 6. Gastrointestinal abnormalities with obvious clinical manifestations, including but not limited to: intestinal obstruction or the presence of symptoms and signs of intestinal obstruction within 6 months before drug administration, but if the obstruction was completely removed after surgical treatment, screening could be performed (patients with previous intestinal stent implantation and the intestinal stent was not removed during the screening period were not allowed); Patients with gastrointestinal perforation, gastrointestinal fistula, intra-abdominal abscess and non-gastrointestinal fistula (such as tracheoesophageal fistula) within 6 months before administration; Patients with gastrointestinal bleeding (CTCAE≥ grade 3) within 6 months before treatment, or gastrointestinal bleeding (melena, bloody stool, etc.) within 1 month before randomization were eligible if hemorrhoid bleeding was confirmed or only showed positive fecal occult blood.\n\n  7\\. Subjects with uncontrolled massive serous effusion or moderate to massive serous effusion requiring repeated drainage (recurrence within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, cachexia, etc.\n\n  8\\. Always received including the antibody coupling of topoisomerase inhibitors class I drug therapy, such as DS-8201, HER3-DXd, DS-1062, etc; 9. A history of (noninfectious) interstitial lung disease (ILD) or noninfectious pneumonia requiring steroid therapy, current ILD or noninfectious pneumonia, or ILD or noninfectious pneumonia that could not be ruled out by imaging at screening; 10. Other malignant tumors within 5 years before drug administration, Cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer (defined as stage ≤T2a, Gleason score ≤6, and at the time of prostate cancer diagnosis) were excluded Patients with PSA≤10ng\u002FmL (if measured) who had received radical treatment and had no PSA biochemical recurrence could participate in the study), in situ prostate\u002Fcervix\u002Fbreast cancer; 11. Have uncontrolled comorbidities, including but not limited to the following:\n* Active HBV or HCV infection Patients with HBsAg (+) and HBV-DNA\\\u003C 2500 copies \u002FmL or 500 IU\u002FmL were allowed to be enrolled. HCV-Ab (+) and HCV-RNA negative were allowed to enroll.\n\n  * HIV infection;\n  * Known active tuberculosis; Active syphilis;\n  * Active or uncontrolled infection requiring systemic anti-infective treatment; Uncontrolled hypertension (systolic blood pressure ≥160mmHg, Diastolic blood pressure \\> 100 mmHg), symptomatic heart failure (NYHA II-IV), unstable angina or myocardial infarction within 6 months, history of heart failure or systolic dysfunction (LVEF\\\u003C50%), or risk of QTc prolongation or arrhythmia (baseline QTc\\>470 msec) ), intractable hypokalemia, long QT syndrome, tachycardia at rest with a heart rate \\>100 bpm, atrial fibrillation or clinically symptomatic valvular heart disease (if well controlled by treatment), moderate-severe pulmonary hypertension, or a history of other arrhythmias of medical importance).\n\nNewly diagnosed thromboembolic events requiring treatment within 6 months (patients with well-controlled deep-vein thrombosis of the lower extremities or venous access ports were allowed).\n\n12\\. The toxicity of previous antineoplastic therapy did not recover to CTCAE grade ≤1 (NCI-CTCAE v5.0); Note: Subjects with stable CTCAE grade 2 toxicity related to previous antineoplastic therapy (defined as stable toxicity severity and no CTCAE grade greater than 2 within 3 months before dose administration) could be enrolled, such as: Chemotherapy-induced neurotoxicity, alopecia, skin pigmentation, fatigue, endocrine toxicity caused by previous immunotherapy (such as thyroid dysfunction, diabetes, hyperglycemia, adrenal insufficiency); 13. Previous history of allogeneic bone marrow or organ transplantation; 14. Previous history of allergic reaction or anaphylaxis to antibody drugs; 15. Previous history of severe dry eye, severe meibomian gland disease and\u002For blepharitis, keratopathy and maculopathy resulting in untreatable or delayed corneal healing of the subject; 16. Pregnant and\u002For lactating women; 17. Other conditions considered by the investigators to affect the safety or compliance of the study drug treatment, including but not limited to mental disorders, alcohol or drug abuse, etc.",{"count":332,"type":21},140,[24],"This is a Phase I open, multi-center, first-in-human study evaluating JSKN016 in subjects with advanced metastatic solid tumors, divided into dose escalation and dose extension.",[148],"2024-09-09",{"date":338,"type":35},"2024-09-19",{"date":340,"type":35},"2024-04-30",{"date":342,"type":21},"2026-12-31",{"name":41,"class":42},""]