[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608993":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":55,"id":58,"slug":25,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"MediLink Therapeutics (Suzhou) Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1： Safety run-in","EXPERIMENTAL","Multiple dose levels of YL201 will be explored in combination with Ivonescimab administered intravenously (IV) at a fixed dose.Participants receive YL201 and Ivonescimab (AK112) on Day 1 of each 3-week cycle, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol.",[13,14],"Drug: YL201","Drug: Ivonescimab",{"label":16,"type":10,"description":17,"interventionNames":18},"Phase 2： Dose expansion","YL201 will be administered at the selected RDE in combination with Ivonescimab administered IV at a fixed dose. Participants receive YL201+ Ivonescimab (AK112) on Day 1 of each 3-week cycle, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","YL201","YL201 will be administered as IV infusion",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Ivonescimab","Ivonescimab will be administered as IV infusion.",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"MediLink Threrapeutics","CONTACT","+86 512 62858368","clinicaltrials@medilinkthera.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":25,"phoneExt":25,"email":25},"Study Coordinator",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[56],{"name":57,"class":6},"Akesobio","100608993",false,"NCT07208773","A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors","A Multi-center, Open-label, Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of YL201 in Combination With Ivonescimab in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Inclusion criteria for the study population： Phase 1: Advanced Solid tumors. Phase 2: Extensive-stage SCLC, Non-AGA NSCLC, EGFR mutation NSCLC.\n3. ECOG PS score is 0 or 1.\n4. Within 7 days before the first dose, the functions of body organs and bone marrow meet the requirements.\n\nExclusion Criteria:\n\n1. Suitable for local curative treatment.\n2. Have received previous treatment with drugs targeting B7-H3 (including antibodies, ADCs, CAR-T, and other drugs).\n3. Have received previous treatment with topoisomerase I inhibitors or ADCs containing topoisomerase I inhibitors.\n4. Have experienced grade ≥ 3 irAEs during previous treatment with anti-programmed death receptor (ligand) \\[anti-PD-(L)1\\] or other immune checkpoint inhibitors.\n5. History of bleeding tendency or coagulation disorders and\u002For clinically significant bleeding symptoms or risks within 4 weeks before randomization.\n6. Imaging studies during the screening period show that the patient has the Imaging-confirmed tumor invasion of major blood vessels.\n7. Active autoimmune disease requiring systemic treatment.\n8. Brain metastases or spinal cord compression.\n9. Patients with uncontrolled or clinically significant cardiovascular diseases.\n10. Clinically significant concurrent pulmonary diseases.\n11. Known to have active pulmonary tuberculosis. Other protocol-defined inclusion\u002F exclusion criteria may apply","ALL","18 Years",{"count":67,"type":68},260,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","This study was designed to evaluate the efficacy and safety of YL201 in combination with Ivonescimab (AK112) in subjects with solid tumor.",[75,76,77],"Advanced Solid Tumors","Non Small Cell Lung Cancer","Small Cell Lung Cancer",[79,80,81,76,77],"Advanced solid tumors","PD1\u002FVEGF Bispecific","Antibody drug conjugate","2026-06-17",{"date":84,"type":85},"2026-06-18","ACTUAL",{"date":87,"type":85},"2025-10-29",{"date":89,"type":68},"2027-12",{"name":5,"class":6},1]