[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tianjin ConjuStar Biologics Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,66],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100599140","phase-2-sc-101-in-subjects-with-advanced-nectin4-amplified-cancers-100599140",false,"NCT07080619","SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers","A Phase IIa Clinical Study to Assess the Efficacy and Safety of SC-101 in Patients With Advanced Malignant Tumors Positive for NECTIN4 Gene Amplification","Inclusion Criteria:\n\nAge between 18 and 75 years (inclusive), regardless of gender.\n\nECOG performance status of 0-1.\n\nExpected survival of more than 3 months, as assessed by the investigator.\n\nFertile participants must agree to use contraception.\n\nAble to understand the trial requirements and willing and able to comply with the trial and follow-up procedures.\n\nAdequate bone marrow and organ function.\n\nNECTIN-4 gene amplification positive.\n\nExclusion Criteria:\n\nUnstable central nervous system tumors.\n\nAdverse reactions from previous anticancer treatments have not recovered to a CTCAE 5.0 grade ≤1.\n\nA history of severe cardiovascular or cerebrovascular disease.","ALL","18 Years","75 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is an open-label, multicenter Phase IIa trial to evaluate the efficacy and safety of SC-101 monotherapy in patients with locally advanced or metastatic malignant tumors who are positive for NECTIN4 gene amplification.",[27,28],"TNBC - Triple-Negative Breast Cancer","HR+ Breast Cancer",[30],"SC-101","NOT_YET_RECRUITING","2025-09-04",{"date":34,"type":35},"2025-09-11","ACTUAL",{"date":37,"type":21},"2025-09-20",{"date":39,"type":21},"2027-12-30",{"name":41,"class":42},"Tianjin ConjuStar Biologics 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":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100570662","phase-1-study-of-sc-102-in-patients-with-advanced-solid-tumors-100570662","NCT06710158","Study of SC-102 in Patients With Advanced Solid Tumors","Phase Ⅰ Study to Evaluate the Safety\u002FTolerability, Pharmacokinetics, and Efficacy of SC-102 in Subjects With Advanced or Metastatic Solid Tumors That Express EphA2","Inclusion Criteria:\n\n1. Subjects voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).\n2. Aged 18 to 75 years at the time of signature of the ICF, without gender limitation.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n4. Life expectancy of ≥ 3 months as assessed by the investigator.\n5. Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the study.\n6. Must be willing and able to comply with the protocol and study procedures.\n7. Acceptable renal, hepatic, hematologic, and coagulation functions.\n8. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n9. Metastatic recurrent histologically confirmed malignant solid tumors and exhausted all appropriate treatment options per local guidelines.\n10. Confirmation of EphA2 expression by the central laboratory prior to enrollment is not required for participants enrolled in the dose escalation study, but required for participants enrolled in the dose expansion study.\n\nExclusion Criteria:\n\n1. History of other malignancy(ies) within 3 years before signing the ICF, except for cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, papillary carcinoma of the thyroid gland, carcinoma in situ of the duct in situ, or other malignant tumors that have survived without disease for more than 5 years.\n2. Any anticancer treatment, including experimental treatments, within 4 weeks before the first dose of the study drug.\n3. Radiotherapy to \\>30% of the bone marrow or extensive radiotherapy within 4 weeks, or local radiotherapy (e.g., radiation therapy to the thoracic spine and ribs) within 7 days, prior to the first dose of the study drug.\n4. Uncontrolled central nervous system metastases.\n5. Preexisting treatment-related toxicity Grade ≥ 2 (except Grade 2 alopecia and hypothyroidism stable with hormone replacement therapy).\n6. Preexisting Grade ≥ 2 (as per CTCAE v5.0) sensory or motor neuropathy.\n7. Major surgery within 4 weeks prior to the first dose of the study drug.\n8. History of interstitial lung disease (ILD), preexisting ILD, or the suspected ILD that cannot be ruled out by imaging examination at screening.\n9. Preexisting serious dermatological diseases, or having experienced serious skin toxicities during the prior anti-cancer treatment (e.g., Stevens-Johnson syndrome, toxic Epidermal Necrolysis, etc.).\n10. Active infection requiring systemic therapy within 14 days prior to the first dose of the study drug.\n11. History of thromboembolic events and bleeding disorders ≤ 3 months (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE)) prior to the first dose of the study drug.\n12. Positive results of virus serology tests.\n13. History of serious cardiovascular and cerebrovascular diseases.\n14. Has received treatment within 2 weeks prior to the first dose of the study drug, or requires ongoing treatment with a medication that is a strong inhibitor or inducer of the cytochrome P450 3A4 (CYP3A4) enzymes.\n15. Known sensitivity to any of the ingredients of the investigational product.",{"count":20,"type":21},[52],"PHASE1","This study will evaluate the safety, PK profile, and anti-cancer efficacy of SC-102 in subjects with advanced solid tumors",[55],"Advanced Solid Cancers","RECRUITING","2025-07-28",{"date":59,"type":35},"2025-07-29",{"date":61,"type":35},"2024-12-05",{"date":63,"type":21},"2027-06",{"name":41,"class":42},1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100533055","phase-1-study-sc-101-in-subjects-with-advanced-malignancies-100533055","NCT06220838","Study SC-101 in Subjects With Advanced Malignancies","A Phase Ⅰ Study to Evaluate the Safety\u002FTolerability, Pharmacokinetics, and Efficacy of SC-101 in Subjects With Advanced or Metastatic Solid Tumors That Express Nectin-4","Inclusion Criteria:\n\n1. Subjects voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).\n2. 18 to 80 years of age at the time of signature of the ICF, without gender limitation.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy of ≥ 3 months as assessed by the investigator.\n5. Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the study.\n6. Understand study requirements, and willing and able to comply with arrangements of study and follow-up procedures.\n7. Adequate Bone Marrow Reserve and Organ Functions.\n8. Subjects must have measurable disease according to RECIST (version 1.1).\n9. Histologically or cytologically confirmed advanced malignant solid tumors.\n10. For non-urothelial carcinoma patients enrolled in the dose expansion study: Subjects must have a positive expression of Nectin-4 in their tumor samples as confirmed by the central laboratory.\n11. Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n1. History of other malignancy(ies) within 3 years before signing the ICF, except for non-melanoma skin cancer, cervical carcinoma in situ, or other malignant tumors that are considered to have been cured.\n2. Any anticancer therapy, including any investigational drug, within 2 weeks before the first dose of the study drug.\n3. Uncontrolled central nervous system metastases.\n4. Prior treatment with Nectin-4-targeting anti-cancer therapy.\n5. Preexisting treatment-related toxicity Grade ≥ 2 (except alopecia).\n6. Preexisting Grade ≥ 2 (as per CTCAE v5.0) sensory or motor neuropathy.\n7. Major surgery within 4 weeks prior to the first dose of the study drug.\n8. History of interstitial lung disease (ILD), preexisting ILD, or the suspected ILD that cannot be ruled out by imaging examination at screening.\n9. Preexisting active keratitis or corneal ulcerations.\n10. Preexisting serious dermatological diseases, or having experienced serious skin toxicities during the prior anti-cancer treatment (e.g., Stevens-Johnson syndrome, toxic Epidermal Necrolysis, etc.).\n11. Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of study drug, or fever within 14 days prior to the first dose of the study drug.\n12. History of uncontrolled diabetes mellitus.\n13. History of thromboembolic events and bleeding disorders ≤ 6 months (e.g.,deep vein thrombosis (DVT) or pulmonary embolism ( PE)) prior to the first dose of the study drug.\n14. Positive results of virus serology tests.\n15. History of serious cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    1. Serious cardiac arrhythmias or conduction abnormalities, such as ventricular arrhythmia require treatment, and grade 2 or 3 atrioventricular block.\n    2. QTc prolongation to \\>450 milliseconds (ms) in males and \\>470 ms in females based on ECG.\n    3. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or transient ischemic attack (TIA) within 6 months prior to the first dose of the study drug.\n    4. New myocardial infarction or unstable angina within 6 months before the first dose of the study drug.\n    5. Uncontrolled hypertension.\n16. Require ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome P450 3A4 (CYP3A4) enzymes.\n17. Known sensitivity to any of the ingredients of the investigational product.","80 Years",{"count":75,"type":21},100,[52],"This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors.",[79],"Advanced Solid Tumor",{"date":59,"type":35},{"date":82,"type":35},"2024-02-02",{"date":84,"type":21},"2026-09",{"name":41,"class":42},5,""]