[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608151":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":20,"studyPopulation":20,"armGroups":38,"interventions":60,"overallOfficials":20,"centralContacts":78,"locations":84,"responsibleParty":267,"collaborators":20,"id":269,"slug":20,"hasResults":270,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":20,"eligibilityCriteria":274,"healthyVolunteers":270,"sex":275,"minAge":276,"maxAge":20,"enrollmentInfo":277,"targetDuration":20,"studyType":280,"phases":281,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":104,"whyStopped":20,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},{"fullName":5,"class":6},"MediLink Therapeutics (Suzhou) Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6)","Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response \\[CR\\] or partial response \\[PR\\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.","Approximately within 36 months",{"measure":14,"description":15,"timeFrame":16},"Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)","AEs will be collected systematically from signing of the informed consent form (ICF) through 42 days after last dose.","Baseline up to 42 days post last patients last dose, approximately within 36 months",[18,21,23,25,27,29],{"measure":19,"description":20,"timeFrame":12},"Area Under the Serum Concentration Time Curve (AUC) of YL242",null,{"measure":22,"description":20,"timeFrame":12},"Maximum Plasma Concentration (Cmax) of YL242",{"measure":24,"description":20,"timeFrame":12},"Time to Maximum Plasma Concentration (Tmax) of YL242",{"measure":26,"description":20,"timeFrame":12},"Incidence of anti-YL242 antibody",{"measure":28,"description":20,"timeFrame":12},"Terminal Elimination Half-life (t1\u002F2) of Serum YL242",{"measure":30,"description":31,"timeFrame":12},"Disease Control Rate (DCR)","Disease control rate (DCR) was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease.",{"allocation":33,"interventionModel":34,"interventionModelDescription":20,"primaryPurpose":35,"observationalModel":20,"timePerspective":20,"maskingInfo":36},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":37,"maskingDescription":20,"whoMasked":20},"NONE",[39,45,50,55],{"label":40,"type":41,"description":42,"interventionNames":43},"Part 1 and Part 2: Mono Dose Escalation & Expansion","EXPERIMENTAL","Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.",[44],"Drug: YL242",{"label":46,"type":41,"description":47,"interventionNames":48},"Part 3 and 4: Combination Dose Escalation & Expansion","Participants receive YL242 at protocol defined dose level, in combination with Pembrolizumab (200 mg), administered via intravenous (IV) solution at protocol defined dose level and frequency.",[49],"Drug: YL242; Pembrolizumab",{"label":51,"type":41,"description":52,"interventionNames":53},"Part 5: Combination Dose Optimization and Expansion","Participants receive YL242, 5-FU and LV, administered via intravenous (IV) solution.",[54],"Drug: YL242; 5-FU; LV",{"label":56,"type":41,"description":57,"interventionNames":58},"Part 6: Combination Dose Optimization and Expansion","Participants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency.",[59],"Drug: YL242; Pembrolizumab; 5-FU",[61,66,70,74],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":20},"DRUG","YL242","The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.",[40],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":20},"YL242; Pembrolizumab","The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. Pembrolizumab will be administered subsequent to YL242.",[46],{"type":62,"name":71,"description":72,"armGroupLabels":73,"otherNames":20},"YL242; 5-FU; LV","The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.\n\nLV and 5-FU will be sequentially administered following YL242.",[51],{"type":62,"name":75,"description":76,"armGroupLabels":77,"otherNames":20},"YL242; Pembrolizumab; 5-FU","The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. YL242 will be administered via Intravenous (IV) Infusion.\n\nPembrolizumab and 5-FU will be administered in sequence after YL242.",[56],[79],{"name":80,"role":81,"phone":82,"phoneExt":20,"email":83},"Medilink Study Team","CONTACT","+86 0512-62858368","clinicaltrials@medilinkthera.com",[85,102,115,127,139,151,163,174,188,195,206,217,229,243,255],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"US-201","NOT_YET_RECRUITING","New Haven","Connecticut","06519","United States","US",{"type":94,"coordinates":95},"Point",[96,97],-72.92816,41.30815,{"lat":97,"lon":96},[100],{"name":101,"role":81,"phone":20,"phoneExt":20,"email":20},"study 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Australia","6009",{"type":94,"coordinates":223},[224,225],115.8073,-31.98184,{"lat":225,"lon":224},[228],{"name":101,"role":81,"phone":20,"phoneExt":20,"email":20},{"facility":230,"status":104,"city":231,"state":232,"zip":233,"country":234,"countryCode":235,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"CN-303","Harbin","Heilongjiang","150081","China","CN",{"type":94,"coordinates":237},[238,239],126.65,45.75,{"lat":239,"lon":238},[242],{"name":101,"role":81,"phone":20,"phoneExt":20,"email":20},{"facility":244,"status":104,"city":245,"state":246,"zip":247,"country":234,"countryCode":235,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"CN-301","Shanghai","Shanghai Municipality","200030",{"type":94,"coordinates":249},[250,251],121.45806,31.22222,{"lat":251,"lon":250},[254],{"name":101,"role":81,"phone":20,"phoneExt":20,"email":20},{"facility":256,"status":104,"city":257,"state":258,"zip":259,"country":234,"countryCode":235,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"CN-302","Hangzhou","Zhejiang","310022",{"type":94,"coordinates":261},[262,263],120.16142,30.29365,{"lat":263,"lon":262},[266],{"name":101,"role":81,"phone":20,"phoneExt":20,"email":20},{"type":268,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100608151",false,"NCT07197827","A Study of YL242 in Subjects With Advanced Solid Tumors","A Phase 1\u002F2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.","Inclusion Criteria:\n\n* Aged ≥18 years.\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1\n* Adequate organ and bone marrow function\n* Tumor type:\n\nPart 1-3: Advanced\u002Funresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy\n\nPart 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy;\n\nPart 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy\n\nPart 6: advanced or metastatic HER2-negative G\u002FGEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy\n\nExclusion Criteria:\n\n* Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor\n* Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases\n* Clinically significant concomitant pulmonary disease\n* A history of leptomeningeal carcinomatosis or carcinomatous meningitis\n* Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance\u002Falcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results","ALL","18 Years",{"count":278,"type":279},424,"ESTIMATED","INTERVENTIONAL",[282,283],"PHASE1","PHASE2","This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant tumors.",[286],"Advanced Solid Tumor",[288,289,290,291],"Oncology","VEGF","Antibody drug conjugate","Developmental Phase I\u002FII","2025-12-23",{"date":294,"type":295},"2025-12-24","ACTUAL",{"date":297,"type":295},"2025-09-22",{"date":299,"type":279},"2028-11",{"name":5,"class":6},15]