[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MediLink Therapeutics (Suzhou) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":403},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,40,68,91,115,140,162,183,206,227,252,272,298,321,341,362,383],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100545626","phase-1-safetytolerability-pharmacokinetics-and-efficacy-of-yl211-in-patients-with-advanced-solid-tumors-100545626",false,"NCT06384352","Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors","A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.\n2. Aged ≥18 years.\n3. Be able and willing to comply with protocol visits and procedures.\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or\n5. Adequate organ and bone marrow function.\n\nFor Part 1: History of an advanced solid tumors (including locally advanced unresectable or metastatic NSCLC, metastatic colorectal carcinoma (mCRC), advanced gastric adenocarcinoma (GAC)\u002F gastroesophageal junction adenocarcinoma (GEJA), pancreatic ductal adenocarcinoma (PDAC), hepatocellular carcinoma (HCC), intrahepatic biliary tract cancer (ih-BTC), and head and neck squamous cell carcinoma (HNSCC) who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit.\n\nFor Part 2: For patients with CRC: History of histologically or cytologically confirmed diagnosis of metastatic CRC and at least 2 prior regimens of standard treatment For patients with NSCLC: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic NSCLC and no more than 2 lines of prior cytotoxic systemic therapy in the locally advanced or metastatic setting.\n\nFor Part 3: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous (Part 3A) or squamous (Part 3B) NSCLC and no more than 2 lines of prior systemic therapy\n\nFor Part 4: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC who have progressed on or after 1 or 2 prior lines of systemic therapy\n\nFor Part 5 and Part 6 Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and\u002For definitive chemoradiotherapy and no prior systemic treatment for advanced unresectable or metastatic NSCLC\n\nExclusion Criteria:\n\n1. Prior treatment with an agent targeting c-MET (including antibody, ADC, chimeric antigen receptor T cell \\[CAR-T\\], and other drugs) with the exception of prior treatment with MET-targeted TKIs which are allowed.\n2. Previously received an ADC consisting of a TopoI\n3. Received continuous systemic steroids therapy for more than 28 days or require long-term (≥ 28 days) use of systemic steroids therapy within 28 days before the first administration, or have other acquired or congenital immune deficiency diseases. (Note: The protocol lists specific situational exceptions immediately following this clause).\n4. A history of leptomeningeal carcinomatosis or carcinomatous meningitis\n5. Brain metastasis, except for the following situations:\n\n   Participants with asymptomatic brain metastasis who do not require immediate local or systemic treatment (such as mannitol or steroids, surgery, or radiotherapy) are allowed to be enrolled If the participant's brain metastasis is treated and the condition of the metastasis is stable (brain imaging examination at least 2 weeks before the first administration shows that the lesion is stable, there is no evidence of new or original brain metastasis enlargement, there are no new neurological symptoms, and immediate local or systemic treatment is not required), admission is allowed\n6. Clinically significant concomitant pulmonary disease, including but not limited to:\n\nA history of drug-induced pneumonitis A history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that requires steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening","ALL","18 Years",{"count":19,"type":20},500,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of six parts. Objectives for Dose-Escalation Parts (Part 1 and Part 4) To evaluate the safety and tolerability of YL211 as monotherapy in patients with selected advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second or third line locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) (Part 4) To determine the maximum tolerated dose (MTD) and select the recommended expansion dose(s) (RED(s)) of YL211 as monotherapy in patients with advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second line locally advanced unresectable or metastatic non-squamous NSCLC (Part 4) Objectives for Backfill Enrollment Parts (Part 2 and Part 5) To better estimate and characterize the safety and efficacy of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) To select the RED(s) of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) Objectives for the Dose-Expansion Parts (Part 3 and Part 6) To further characterize the safety and efficacy of YL211 as monotherapy (Part 3) in patients with locally advanced unresectable or metastatic non-squamous or squamous NSCLC and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non- squamous NSCLC (Part 6) To compare the clinical activity of YL211 in combination with pembrolizumab against pembrolizumab, pemetrexed, and platinum-based chemotherapy (cisplatin or carboplatin) in participants with previously untreated advanced unresectable or metastatic non-squamous NSCLC (Part 6)",[26],"Advanced Solid Tumors","RECRUITING","2026-06-24",{"date":30,"type":31},"2026-06-29","ACTUAL",{"date":33,"type":31},"2024-05-01",{"date":35,"type":20},"2031-06-30",{"name":37,"class":38},"MediLink Therapeutics (Suzhou) Co., Ltd.","INDUSTRY",21,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100608993","phase-1-a-study-of-yl201-and-ivonescimab-ak112-in-advanced-solid-tumors-100608993","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",{"count":48,"type":20},260,[23,50],"PHASE2","This study was designed to evaluate the efficacy and safety of YL201 in combination with Ivonescimab (AK112) in subjects with solid tumor.",[26,53,54],"Non Small Cell Lung Cancer","Small Cell Lung Cancer",[56,57,58,53,54],"Advanced solid tumors","PD1\u002FVEGF Bispecific","Antibody drug conjugate","2026-06-17",{"date":61,"type":31},"2026-06-18",{"date":63,"type":31},"2025-10-29",{"date":65,"type":20},"2027-12",{"name":37,"class":38},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100472619","phase-1-a-study-of-yl201-in-patients-with-advanced-solid-tumors-100472619","NCT05434234","A Study of YL201 in Patients With Advanced Solid Tumors","A Phase 1A\u002F1B, Multicenter, Nonrandomized, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL201 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF\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* Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of YL201, whichever is later. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of YL201.\n* Life expectancy of ≥3 months\n* Able and willing to comply with protocol visits and procedures\n* Have at least 1 evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Pathologically confirmed diagnosis of an advanced solid tumor (SCLC, mCRPC, ESCC and NSCLC are preferred) for which standard treatment had proven to be ineffective or intolerable, or no standard treatment is available. For ES-SCLC patients in Arm C: no prior anti-cancer treatment\n\nExclusion Criteria:\n\n* Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study\n* Prior systemic anticancer treatment including chemotherapy, molecular -targeted therapy, hormonal therapy, immunotherapy, or biological therapy within 3 weeks before the first dose of study drug (use of oral fluorouracil \\[eg, tegafur and capecitabine\\] or small molecular-targeted therapy within 2 weeks or 5 half-life periods \\[whichever is shorter\\]before the first dose; use of mitomycin or nitrosoureas within 6 weeks before the first dose; use of herbal medicine with antitumor indications or nonspecific immunomodulators \\[eg, thymosin, interferon, and interleukin\\] within 2 weeks before the first dose).\n* Prior radiation therapy, including palliative stereotactic radiation with abdominal, within 4 weeks before the first dose of study drug (if palliative stereotactic radiation therapy without abdominal, within 2 weeks)\n* Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study\n* Undergone allogeneic hematopoietic stem cell transplantation (HSCT) before the first dose of study drug, or autologous HSCT within 3 months before the first dose of study drug\n* Received systemic steroids (\\>10 mg\u002Fday of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study\n* Known human immunodeficiency virus (HIV) infection\n* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Active HBV is defined as hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) positive, and HBV DNA level above ULN at the study site; active HCV is defined as positive hepatitis C antibody and HCV RNA level above ULN at the study site\n* Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion\u002Fexclusion criteria. Patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be enrolled after discussion with the sponsor\n* A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other mAbs\n* Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 7 days before the first dose",{"count":76,"type":20},312,[23,50],"This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2).\n\nPart 1 will estimate the MTD\u002FRED(s) in dose escalation cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available.\n\nPart 2 will include patients with selected advanced solid tumor types enrolled at the MTD\u002FRED(s), to better define the safety profile and evaluate the efficacy of YL201.",[80],"Advanced Solid Tumor",[82],"Antibody-drug conjugate",{"date":84,"type":31},"2026-06-22",{"date":86,"type":31},"2022-05-25",{"date":88,"type":20},"2027-10-06",{"name":37,"class":38},45,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100624307","phase-1-a-study-of-yl201-in-combination-with-other-anti-cancer-therapies-in-patients-with-advanced-solid-tumors-100624307","NCT07407933","A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors","A Phase Ib\u002FII, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1.18 years of age or older. 2. Histologically or cytologically confirmed diagnosis of ES-SCLC 3. Eastern Cooperative Oncology Group performance status of 0 or 1 4. Adequate hematologic and end-organ function\n\nExclusion Criteria:\n\n1. No prior systemic anti-cancer treatment for ES-SCLC\n2. No prior treatment targeting B7H3 or topoisomerase I inhibitor\n3. No clinically active brain metastases or spinal cord compression\n4. No current or history of interstitial lung disease (ILD)\u002F pneumonitis\n5. No clinically significant cardiovascular disease (eg, New York Heart Association class II to IV congestive heart failure)\n\nOther protocol-defined inclusion\u002F exclusion criteria may apply.",{"count":99,"type":20},118,[23,50],"This is a phase Ib\u002FII, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg\u002Fkg, 1.6 mg\u002Fkg and 2.0 mg\u002Fkg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg\u002Fkg,1.6 mg\u002Fkg or 2.0 mg\u002Fkg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.",[103],"Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma",[105],"Small cell lung cancer, Antibody drug conjugate, YL201, atezolizumab","2026-06-11",{"date":108,"type":31},"2026-06-15",{"date":110,"type":31},"2026-03-31",{"date":112,"type":20},"2029-02",{"name":37,"class":38},22,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100625004","phase-3-pivotal-study-to-evaluate-yl202-versus-docetaxel-in-patients-with-locally-advanced-or-metastatic-egfr-sensitive-mutation-non-squamous-non-small-cell-lung-cancer-100625004","NCT07416994","Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer","A Multicenter, Randomized, Open-label, Phase III Study to Compare the Efficacy and Safety of YL202 and Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Males or females aged ≥18 to ≤75 years at the time of signing the ICF\n2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.\n3. Received one prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the locally advanced, or metastatic setting, either as monotherapy or in combination with other agents; Received one prior platinum based chemotherapy in the locally advanced, or metastatic setting, either prior to TKI, in combination with TKI, or after TKI therapy.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n5. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.\n6. Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.\n7. Current, historical, or suspected interstitial lung disease (ILD)\u002Fpneumonitis.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%;\n2. Other malignancies within 5 years prior to the first dose;\n3. History of (noninfectious) interstitial lung disease (ILD) and current ILD\n4. Prior HER3-targeted therapy; Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);\n5. Pregnant or lactating women;","75 Years",{"count":124,"type":20},440,[126],"PHASE3","Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to evaluate YL202 monotherapy versus Docetaxel in participants with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy and platinum-based chemotherapy.",[129],"Non-Small Cell Lung Cancer",[129,131],"EGFR-Mutated","2026-06-10",{"date":108,"type":31},{"date":135,"type":31},"2026-03-18",{"date":137,"type":20},"2028-08-31",{"name":37,"class":38},2,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":147,"minAge":17,"maxAge":122,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":67},"100628424","phase-3-yl202-versus-treatment-of-physicians-choice-in-patients-with-hrher2--breast-cancer-100628424","NCT07461454","YL202 Versus Treatment of Physician's Choice in Patients With HR+\u002FHER2- Breast Cancer","A Randomized, Open-label, Multicenter, Phase 3 Study of YL202 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+\u002FHER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy","Inclusion Criteria:\n\n1. Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.\n2. Histologically and\u002For cytologically confirmed locally advanced or metastatic HR+\u002FHER2- breast cancer who are not candidates for curative surgery or radiotherapy.\n3. Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage.\n4. Have at least 1 extracranial measurable lesion as a target lesion per RECIST 1.1.\n5. Tumor tissue samples can be provided at the time of diagnosis of locally advanced or metastatic tumors.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n7. Have Adequate organ and bone marrow function within 7 days prior to the first dose.\n8. Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.\n9. Have a expected survival ≥ 3 months.\n10. Have ability and willingness to comply with protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n1. Have prior treatment with an agent targeting HER3.\n2. Have prior treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.\n3. Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.\n4. Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study.\n5. Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.\n6. Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.\n7. Have clinically significant concomitant pulmonary diseases.\n8. Have uncontrolled pleural effusion, abdominal effusion.\n9. Have serious infection within 4 weeks prior to the first dose.\n10. Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.","FEMALE",{"count":149,"type":20},376,[126],"The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally advanced, recurrent or metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+\u002FHER2-) breast cancer who had failed at least one line of chemotherapy.",[153],"Locally Advanced or Metastatic Breast Cancer","2026-05-21",{"date":156,"type":31},"2026-05-26",{"date":158,"type":31},"2026-03-17",{"date":160,"type":20},"2028-06-30",{"name":37,"class":38},{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":67},"100630455","phase-3-a-study-of-yl201-versus-investigators-choice-of-chemotherapy-in-participants-with-locally-advanced-or-metastatic-esophageal-squamous-cell-carcinoma-after-failure-of-first-line-therapy-100630455","NCT07487896","A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy","A Randomized, Controlled, Multicenter Phase III Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy (TAISHAN-303)","Inclusion Criteria:\n\n1. Age: ≥18 years;\n2. Voluntary participation in this study with signed informed consent and good compliance.\n3. ECOG PS score: 0-1;\n4. estimated life expectancy \\>3 months;\n5. Histologically or cytologically confirmed ESCC with unresectable locally advanced or metastatic disease\n6. Previously received one line of systemic standard therapy for unresectable locally advanced or metastatic ESCC and experienced disease progression\n7. Adequate organ function.\n8. At least one measurable lesion\n9. Willing to provide biopsy or archived tumor tissue.\n\nExclusion Criteria:\n\n1. Other malignancies within 5 years prior to first dose or currently concurrent malignancies.\n2. Prior treatment-related adverse events not resolved to ≤Grade 1 per CTCAE v5.0, except for alopecia (any grade), hyperpigmentation (any grade), peripheral neuropathy (≤ Grade 2), and lymphopenia (≤ Grade 3).\n3. Major surgery, significant traumatic injury within 4 weeks prior to first dose, or anticipated need for major surgery during study treatment\n4. Any arterial thromboembolic event within 6 months prior to randomization, or venous thromboembolic events of Grade ≥ 3 according to NCI CTCAE version 5.0.\n5. Known active tuberculosis (TB). Participants suspected of having active TB must undergo clinical evaluation to rule it out.\n6. History of immunodeficiency or positive test for human immunodeficiency virus (HIV) antibodies. Participants with known active syphilis infection are also excluded.\n7. Current active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).\n8. Known allergy to any component of the investigational product; history of severe allergic reactions (e.g., anaphylactic shock); or known history of severe hypersensitivity reactions to other monoclonal antibodies or recombinant proteins, or previous severe infusion reactions.\n9. Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period.\n10. Any disease, medical condition, organ dysfunction, or social\u002Fpsychological circumstance that, in the investigator's judgment, may interfere with the participant's ability to sign the informed consent form (ICF), compromise cooperation or compliance with study procedures, or affect the interpretation of study results. This includes, but is not limited to, psychiatric disorders, substance\u002Falcohol abuse, or a history of drug abuse.",{"count":124,"type":20},[126],"This is a large clinical study carried out at multiple hospitals. Participants will be randomly assigned to one of two groups: one group will receive a new medicine called YL201, and the other group will receive standard chemotherapy chosen by the doctor.\n\nThe purpose of the study is to see whether YL201 works better and is safer for people with locally advanced or metastatic esophageal squamous cell carcinoma whose first-line treatment has stopped working.\n\nThe study will also look at how YL201 is processed in the body (Pharmacokinetics), whether it triggers any immune reactions, and whether certain biological markers can help predict how well it works.",[173],"Advanced Esophageal Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-03-24",{"date":177,"type":31},"2026-03-30",{"date":179,"type":20},"2026-04-30",{"date":181,"type":20},"2028-12-31",{"name":37,"class":38},{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":67},"100608500","phase-2-a-study-of-yl202-in-patients-with-advanced-solid-tumors-100608500","NCT07202364","A Study of YL202 in Patients With Advanced Solid Tumors","A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects must meet all the following criteria to be included in the study:\n\n  1. Subjects who are aware of relevant study information prior to the start of the study, and voluntarily sign and date on the informed consent form (ICF).\n  2. Subjects aged ≥18 years at the time of giving informed consent\n  3. Body mass index (BMI) within the range of 18 to 32 kg\u002Fm2.\n  4. Subjects with histologically or cytologically confirmed non-Sq NSCLC\u002FCRC\u002FCC or other advanced solid tumor, and had received 1-2 lines of systemic therapy in the advanced\u002Fmetastatic setting\n  5. There is at least one extracranial measurable lesion as the target lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n  6. Archived or fresh tumor tissue samples are available.\n  7. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n  8. The function of organs and bone marrow meets the requirements within 7 days prior to the first dose\n  9. Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product.\n  10. Expected survival ≥3 months.\n  11. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.\n\nExclusion criteria\n\n* Subjects who meet any of the following criteria should be excluded from the study:\n\n  1. Prior drug therapy targeting HER3\n  2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors).\n  3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.\n  4. The washout period from the previous anti-tumor therapy is insufficient prior to the first dose of the investigational product.\n  5. Patients who received major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of the investigational product or those who are expected to receive major surgery during the study.\n  6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.\n  7. Prior treatment with systemic steroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational product.\n  8. Patients who received any live vaccine within 4 weeks prior to the first dose of the investigational product or those who plan to receive live vaccine during the study period.\n  9. Meningeal metastasis or cancerous meningitis.\n  10. Brain metastasis or spinal cord compression.\n  11. Patients with uncontrolled or clinically significant cardiovascular diseases.\n  12. Clinically significant complicated pulmonary disorders.\n  13. Medical history of hepatic encephalopathy within 6 months prior to the first dose.\n  14. Subjects with active or chronic corneal disorders, or other active eye disorders requiring continuous treatment, or any clinically significant corneal disorders that preclude adequate monitoring of drug-induced keratopathy.\n  15. Diagnosed with Gilbert's syndrome.\n  16. Significantly symptomatic or unstable pleural effusion, peritoneal effusion, and pericardial effusion, or those requiring repeated drainage.\n  17. Medical history of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose, or active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may cause hemorrhage or perforation in the opinion of the investigator.\n  18. Serious infection prior to the first dose (National Cancer Institute-Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] v5.0 grade ≥3),\n  19. Patients with severe coagulopathy or other diseases with evident risk of bleeding.\n  20. Patients with uncontrolled diabetes mellitus.\n  21. Human immunodeficiency virus (HIV) infection; positive syphilis antibody and a positive titer result.\n  22. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n  23. Medical history of any other primary malignancies within 5 years prior to the first dose of the investigational product, except fully resected non-melanoma skin cancer, cured in-situ disease, or other cured solid tumors.\n  24. Unresolved toxicity of previous anti-tumor therapy,\n  25. History of severe hypersensitivity to inactive ingredients in the drug substance (DS) and drug product (DP) or other monoclonal antibodies.\n  26. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days prior to the first dose.\n  27. Have any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the subject ability to sign the ICF, adversely affect the subject ability to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance\u002Falcohol abuse, in the opinion of the investigator.",{"count":191,"type":20},100,[50],"This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in selected patients with advanced solid tumors.",[53,195,196,197],"Colorectal Cancer","Cervical Cancer","Locally Advanced or Metastatic Solid Tumors","2026-03-05",{"date":200,"type":31},"2026-03-09",{"date":202,"type":31},"2025-08-04",{"date":204,"type":20},"2027-02-28",{"name":37,"class":38},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":21,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},"100582165","phase-1-a-first-in-human-study-of-yl217-in-patients-with-advanced-solid-tumors-100582165","NCT06859762","A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors","A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Informed of the study before the start of the study and voluntarily sign their name and date in the ICF\n* Able and willing to comply with protocol visits and procedures\n* Age≥ 18 years\n* ECOG PS of 0 or 1\n* Tumor types as below:\n\nFor Part 1 and Part 2: Pathologically confirmed diagnosis of an advanced solid tumor.\n\nFor Part 3 (Histologically or cytologically confirmed diagnosis+ locally advanced unresectable or metastatic disease)\n\n* Adequate organ and bone marrow function.\n* Have at least 1 extracranial measurable tumor lesion.\n* Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy.\n\nExclusion Criteria:\n\n* Prior treatment with an agent targeting CDH17\n* Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities.\n* Have received an ADC consisting of a topoisomerase I inhibitor.\n* Concurrent enrollment in another clinical study, unless it is an observational clinical study.\n* Inadequate washout period for prior anticancer treatment before the first dose of study drug\n* Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study.\n* Received long term systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.\n* Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.\n* Diagnosis or evidence of spinal cord compression or leptomeningeal carcinomatosis.\n* Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.\n* A history of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that requires steroids, current active ILD\u002Fpneumonitis.\n* Have clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.\n* Uncontrolled third-space fluid that requires repeated drainage.\n* Digestive system disease that may cause bleeding, perforation, jaundice, gastrointestinal obstruction.\n* An active tuberculosis based on medical history.\n* Known human immunodeficiency virus (HIV) infection.\n* Active hepatitis C infection.",{"count":214,"type":20},220,[23],"A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors",[80],"2026-01-12",{"date":220,"type":31},"2026-01-14",{"date":222,"type":31},"2025-07-02",{"date":224,"type":20},"2027-07",{"name":37,"class":38},19,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":21,"phases":236,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":251},"100608151","phase-1-a-study-of-yl242-in-subjects-with-advanced-solid-tumors-100608151","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",{"count":235,"type":20},424,[23,50],"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.",[80],[240,241,58,242],"Oncology","VEGF","Developmental Phase I\u002FII","2025-12-23",{"date":245,"type":31},"2025-12-24",{"date":247,"type":31},"2025-09-22",{"date":249,"type":20},"2028-11",{"name":37,"class":38},15,{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100551429","phase-1-a-clinical-study-of-yl205-in-patients-with-advanced-solid-tumors-100551429","NCT06459973","A Clinical Study of YL205 in Patients With Advanced Solid Tumors","A Multi-center, Open-label, Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of YL205 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\) Subjects who are informed of relevant information of the study prior to initiation of the study and voluntarily sign and date on the informed consent form (ICF).\n\n  2\\) Age ≥18 years. 3) Be willing to follow and be able to complete all the study procedures. 4) Body mass index (BMI) within the range of 18 to 32 kg\u002Fm2, and body weight ≥45kg for female subjects.\n\n  5） Patients with histologically or cytologically confirmed locally advanced or metastatic ovarian cancer (OC), non-squamous non-small cell lung cancer (NSQ NSCLC), renal cell carcinoma (RCC), endometrial cancer (EC), or other Napi2b-overexpressing tumors。 6) Patients with positive Napi2b test results at the central laboratory. 9) At least one radiologically evaluable lesion for subjects in Part 1; At least one measurable extracranial lesion (non-radiation fields) for subjects in Part 2 and Part 3.\n\n  10\\) Expected survival ≥3 months. 11) Female subjects of childbearing potential must agree to take effective contraceptive measures and must not undergo egg donation or egg retrieval for their own use from screening throughout the study period and for at least 6 months after the last dose of the investigational drug. Male subjects must agree to take effective contraceptive measures and must not undergo sperm cryopreservation or sperm donation from screening throughout the study period and for at least 6 months after the last dose of the investigational drug.\n\n  12\\) subjects must provide tumor samples. 13) Subjects who are capable of and willing to comply with the visits and procedures stipulated in the study protocol.\n\nExclusion Criteria:\n\n* 1\\) Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with a history of intolerance to topoisomerase I inhibitors or ADC therapy.\n\n  3\\) Subjects who are participating in another clinical study, with the exception an of observational (non-interventional) clinical study or the follow-up period of an interventional study.\n\n  4\\) Subjects with an insufficient washout period from the previous anti-tumor therapy to the first dose.\n\n  5\\) Subjects who received radiotherapy, including palliative stereotactic radiotherapy on the abdomen, within 4 weeks prior to the first dose.\n\n  6\\) Subjects who received major surgery within 4 weeks prior to the first dose or those who plan to receive major surgery during the study.\n\n  7\\) Subjects who received allogeneic bone marrow transplantation or solid organ transplantation.\n\n  8\\) Subjects who received systemic steroids or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational drug.\n\n  9\\) Subjects who received any live vaccine within 4 weeks prior to the first dose or those who plan to receive live vaccines during the study.\n\n  10\\) Subjects with a medical history of leptomeningeal carcinoma or cancerous meningitis.\n\n  11\\) Subjects with brain metastasis or spinal cord compression. 12) Subjects with uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.\n\n  13\\) Subjects who were diagnosed with Gilbert's syndrome. 14) Subjects with significantly symptomatic or unstable effusion in the third space requiring repeated drainage.\n\n  15\\) Subjects with medical history of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose, or active gastric ulcers, duodenal ulcer, colitis ulcerative, or other gastrointestinal disorders that may cause hemorrhage or perforation in the opinion of the investigator.\n\n  16\\) Subjects with serious infection (Grade ≥3 as per NCI CTCAE v5.0) prior to the first dose.\n\n  17\\) Subjects with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; subjects with positive syphilis antibody and a positive titer result.\n\n  18\\) Subjects with unresolved toxicity caused by previous anti-tumor therapy. 20) Subjects with a history of serious allergic reactions to drugs, inactive ingredients in drug products, or other monoclonal antibodies.\n\n  21\\) Female subjects who are pregnant as confirmed by a pregnancy test within 3 days prior to the first dose, or lactating women.\n\n  22\\) Subjects who have any diseases, medical conditions, organ system dysfunction, or social conditions.\n\n  23\\) Subjects with multiple primary malignancies within 5 years prior to the signing of the ICF, except for fully resected non-melanoma skin cancer, radically treated carcinoma in situ, or other radically treated solid tumors.",{"count":260,"type":20},252,[23,50],"This study is a multicenter, open-label, phase I\u002FII study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.",[26],"2025-12-21",{"date":243,"type":31},{"date":267,"type":31},"2024-06-04",{"date":269,"type":20},"2030-07-31",{"name":37,"class":38},43,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},"100612853","phase-1-a-study-of-yl201-in-combination-with-toripalimab-and-with-or-without-cisplatin-in-nasopharyngeal-carcinoma-100612853","NCT07258979","A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.","A Multicenter, Open-label, Phase Ib\u002FII Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 Combined With Toripalimab, With or Without Cisplatin, in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma.","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form (ICF).\n2. Aged ≥18 years and ≤75 years, male or female.\n3. ECOG performance status score of 0 or 1.\n4. Life expectancy ≥ 3 months.\n5. Disease and treatment history:\n\n   1. Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment.\n   2. Patients with newly diagnosed advanced nasopharyngeal carcinoma, categorized as Stage IV according to the 9th Edition of the American Joint Committee on Cancer (AJCC) Staging System; or those with recurrent nasopharyngeal carcinoma deemed unsuitable for local treatment\n   3. Metastatic or recurrent patients who are systemic treatment naïve.\n6. At least one measurable lesion according to RECIST v1.1.\n7. Adequate organ function.\n\nExclusion Criteria:\n\n1. History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects who have been cured of other tumors by local therapy, such as basal cell carcinoma, squamous cell carcinoma of skin, bladder cancer in situ, cervical carcinoma in situ, or breast cancer in situ, are not excluded.\n2. Patients with brainstem metastases, leptomeningeal metastases, spinal cord metastases, or spinal cord compression.\n3. Patients with severe, uncontrolled cardiovascular disease.\n4. Patients with concomitant pulmonary disease resulting in clinically severe impairment of respiratory function.\n5. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring corticosteroid therapy, OR current ILD or non-infectious pneumonitis.\n6. Prior treatment with a B7-H3 targeted therapy (including antibodies, antibody-drug conjugates \\[ADCs\\], CAR-T cells, and other agents), or with a topoisomerase I inhibitor or an ADC containing a topoisomerase I inhibitor payload.\n7. Prior treatment with a PD-(L)1 inhibitor (including antibodies, antibody-drug conjugates \\[ADCs\\], CAR-T cells, and other agents).",{"count":280,"type":20},202,[23,50],"This is a multicenter, open-label, Phase Ib\u002FII study conducted in China to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of YL201 combined with Toripalimab (doublet regimen) or YL201 combined with Toripalimab and Cisplatin (triplet regimen) in subjects with recurrent or metastatic nasopharyngeal carcinoma.",[284],"Recurrent or Metastatic Nasopharyngeal Carcinoma",[286,287,288],"YL201","recurrent or metastatic nasopharyngeal carcinoma","Toripalimab","2025-11-21",{"date":291,"type":31},"2025-12-02",{"date":293,"type":31},"2025-11-05",{"date":295,"type":20},"2028-05",{"name":37,"class":38},20,{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":188,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":304,"targetDuration":4,"studyType":21,"phases":306,"briefSummary":307,"conditions":308,"keywords":312,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":319,"locationsCount":320},"100524358","phase-2-a-study-of-yl202-in-selected-patients-with-advanced-solid-tumors-100524358","NCT06107686","A Study of YL202 in Selected Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects who are aware of relevant trial information before the start of the trial, and voluntarily sign and date on the informed consent form (ICF).\n2. Subjects aged from 18-75 (inclusive) years.\n3. Histologically or cytologically confirmed at diagnosis of NSCLC\u002FBC\u002FHNSCC\u002Fother locally advanced or metastatic solid tumors including but not limited to colorectal cancer, HER2-positive gastric cancer, cervical cancer, ovarian cancer, etc..\n4. At least one extracranial measurable lesion according to RECIST 1.1.\n5. Archived or fresh tumor tissue samples can be provided.\n6. With Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n7. The function of organs and bone marrow meets the requirements within 7 days before the first dose.\n8. Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product.\n9. With expected survival ≥ 3 months.\n10. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.\n\nExclusion Criteria:\n\n1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates \\[ADCs\\]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).\n2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.\n3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.\n4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.\n5. Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.\n6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.\n7. Prior treatment with systemic steroids (prednisone \\> 10 mg\u002Fday or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.\n8. Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.\n9. With meningeal metastasis or cancerous meningitis.\n10. With brain metastasis or spinal cord compression.\n11. Patients with uncontrolled or clinically significant cardiovascular diseases.\n12. Clinically significant complicated pulmonary disorders.\n13. Patients diagnosed with Gilbert syndrome.\n14. Those with uncontrolled effusion in the third space requiring repeated drainage.\n15. With a medical history of gastrointestinal perforation and\u002For fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator.\n16. With serious infection before the first dose.\n17. With known human immunodeficiency virus (HIV) infection.\n18. With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n19. With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.\n20. Unrelieved toxicity of previous anti-tumor therapy.\n21. With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.\n22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.\n23. With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance\u002Falcohol abuse, in the opinion of the investigator.",{"count":305,"type":20},200,[50],"This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.",[309,310,311,197],"NSCLC","Breast Cancer","HNSCC",[82],"2025-11-20",{"date":315,"type":31},"2025-11-26",{"date":317,"type":31},"2023-12-15",{"date":249,"type":20},{"name":37,"class":38},82,{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":328,"targetDuration":4,"studyType":21,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":297},"100606011","phase-1-a-study-of-yl202-in-combination-with-other-anti-tumor-therapies-in-patients-with-advanced-solid-tumors-100606011","NCT07169994","A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors","A Multi-center, Open-Label, Phase Ib\u002FII Study of YL202 in Combination With Anti-tumor Therapy to Evaluate the Safety, Tolerability, and Efficacy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF)\n2. Able and willing to comply with protocol visits and procedures\n3. Aged between 18 to 75 years\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1\n5. Previously treated by standard treatment or have not been treated for metastatic setting;\n6. Adequate organ and bone marrow function.\n7. Have at least 1 extracranial measurable tumor lesion.\n8. Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy.\n\nExclusion Criteria:\n\n1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates \\[ADCs\\]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).\n2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.\n3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.\n4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.\n5. Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.\n6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.\n7. Prior treatment with systemic steroids (prednisone \\> 10 mg\u002Fday or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.\n8. Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.\n9. With meningeal metastasis or cancerous meningitis.\n10. With brain metastasis or spinal cord compression.\n11. Patients with uncontrolled or clinically significant cardiovascular diseases.\n12. Clinically significant complicated pulmonary disorders.\n13. Patients diagnosed with Gilbert syndrome.\n14. Those with uncontrolled effusion in the third space requiring repeated drainage.\n15. With a medical history of gastrointestinal perforation and\u002For fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator.\n16. With serious infection before the first dose.\n17. With known human immunodeficiency virus (HIV) infection.\n18. With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n19. With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.\n20. Unrelieved toxicity of previous anti-tumor therapy.\n21. With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.\n22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.\n23. With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance\u002Falcohol abuse, in the opinion of the investigator.",{"count":329,"type":20},414,[23,50],"This is a multicenter, open-label, phase Ib\u002FII study of YL202 in combination with other anti-tumor therapies to Evaluate the Safety, Tolerability, and Efficacy in Patients with Advanced Solid Tumors",[26,310,53],"2025-09-10",{"date":335,"type":31},"2025-09-12",{"date":337,"type":31},"2025-09-02",{"date":339,"type":20},"2027-11-30",{"name":37,"class":38},{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":348,"minAge":17,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":360,"locationsCount":361},"100534670","phase-2-a-phase-ii-study-to-evaluate-the-safety-efficacy-and-pharmacokinetics-of-yl201-in-patients-with-mcrpc-100534670","NCT06241846","A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC","A Multicenter, Open-Label, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n1. Subjects who understand relevant information of the study prior to initiation of the study and voluntarily sign and date on the ICF.\n2. Age ≥ 18 years.\n3. Patients should meet the following conditions to be enrolled:\n\n   * Histologically or cytologically confirmed prostate cancer. Note: The primary histological classification indicated by biopsy should be adenocarcinoma;\n   * Meeting the following criteria for clinical diagnosis of mCRPC:\n\n\u003C!-- -->\n\n1. Subjects who understand relevant information of the study prior to initiation of the study and voluntarily sign and date on the ICF.\n2. Age ≥ 18 years.\n3. Patients should meet the following conditions to be enrolled:\n\n   • Histologically or cytologically confirmed prostate cancer. Note: The primary histological classification indicated by biopsy should be adenocarcinoma;\n\n   • Meeting the following criteria for clinical diagnosis of mCRPC:\n\n   √Testosterone level after castration (a serum testosterone level of \\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL);\n   * Serum prostate specific antigen (PSA) progression (PSA \\> 1 ng\u002FmL and 2 consecutive increases in PSA with at least a 1-week interval \\>50% from baseline), or PD by imaging (≥ 2 new bone lesions suggested by a bone scan according to PCWG3 criteria; and\u002For progression of soft tissue lesions suggested by computed tomography (CT) or nuclear magnetic resonance imaging (MRI) according to RECIST v1.1); meeting either or both criteria;\n   * Persistent luteinizing hormone-releasing hormone (LHRH) analogue castration (medical castration) or prior bilateral orchiectomy (surgical castration); surgical castration should be performed at least 3 months prior to enrollment, and medical castration is required from at least 3 months prior to the first dose and throughout the study for subjects not yet undertake bilateral orchiectomy; • Patients with progression on or intolerance to at least one prior novel hormone therapy (NHT) (e.g., enzalutamide, abiraterone, darolutamide, apalutamide, or rezvilutamide); • Prior therapy with no more than 2 lines of chemotherapy is allowed; • Patients with known previous prostate adenocarcinoma with a documented BRCA1\u002F2 (germline or somatic) mutation should have received poly ADP ribose polymerase (PARP) inhibitor therapy (if available and tolerated);\n4. Patients with metastatic lesions confirmed by CT, MRI, or bone scan imaging within 28 days prior to the first dose.\n5. Patients with archived or fresh tumor tissue samples. Patients who cannot provide tumor samples or cannot provide sufficient samples may be enrolled in this study after considering specific circumstances and discussions with the Sponsor.\n\n   • Fresh tumor tissue samples (formalin-fixed, paraffin-embedded (FFPE) tumor blocks or FFPE sections) should be provided for retrospective detection of B7H3 expression by the central laboratory using the immunohistochemistry \\[IHC\\] method; if fresh tumor tissue samples are not available, FFPE tumor blocks previously archived are acceptable, and fresh FFPE sections should be prepared within 2 weeks.\n6. Eastern cooperative oncology group performance status (ECOG PS) score of 0 or 1.\n7. The function of organs and bone marrow meets the requirements within 7 days prior to the first dose, which is defined as follows:\n\n   • Hemoglobin (Hb) ≥ 90 g\u002FL (no blood transfusion or erythropoietin treatment within 14 days prior to the first dose);\n\n   • Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL (no treatment with granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor within 14 days prior to the first dose);\n\n   • Platelet count (PLT) ≥ 100×109\u002FL (no platelet transfusion, thrombopoietin, or interleukin-11 within 14 days prior to the first dose);\n\n   • Total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN) in the absence of obvious liver metastasis, or ≤ 3×ULN in the presence of liver metastasis;\n\n   • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN in the absence of obvious liver metastasis or ≤ 5×ULN in the presence of liver metastasis;\n\n   • Serum albumin (ALB) ≥ 30 g\u002FL;\n\n   • Creatinine clearance calculated using Cockcroft-Gault formula ≥ 50 mL\u002Fmin or the creatinine ≤ 1.5×ULN;\n   * Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN, except for patients who are on anticoagulant therapy. In this case, a stable anticoagulant regimen should be maintained with APTT and INR controlled within the range deemed appropriate by the investigator.\n8. Patients must agree to adopt highly effective contraceptive measures from screening, throughout the study period, and within at least 6 months after the last dose of the investigational drug.\n9. Expected survival ≥ 6 months.\n10. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.\n\nExclusion Criteria:\n\n1. Previously treated with drugs targeting B7H3.\n2. Currently participating in another clinical study, unless it is an observational (non-interventional) clinical study, or the patient is at the follow-up period of an interventional study.\n3. Previously treated with topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.\n4. The washout period of the previous anti-tumor therapy is considered insufficient.\n5. Patients received major surgery.\n6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.\n7. Prior treatment with glucocorticoids for more than 28 consecutive days within 28 days prior to the first dose of the investigational drug.\n8. Patients received any live vaccine within 4 weeks prior to the first dose of the investigational drug, or plan to receive live vaccine during the study period.\n9. Have pathological long bone fracture, or the risk of pathological long bone fracture.\n10. Have meningeal metastasis or cancerous meningitis.\n11. Have uncontrolled bladder outlet obstruction or urinary incontinence.\n12. Have brain metastasis or spinal cord compression.\n13. Patients with uncontrolled or clinically significant cardiovascular diseases.\n14. Clinically significant complicated pulmonary disorders.\n15. Diagnosed with Gilbert's syndrome.\n16. Accompanying uncontrolled effusion in the third space requiring repeated drainage.\n17. Medical history of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose, or active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may cause hemorrhage or perforation in the opinion of the investigator.\n18. Active serious infection (National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] ≥ 3) within 4 weeks prior to the first dose.\n19. Known human immunodeficiency virus (HIV) infection.\n20. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n21. Diagnosed with the other malignancies that may change the expected survival or affect the response evaluation.\n22. Unresolved toxicity of previous anti-tumor therapy.\n23. History of severe hypersensitivity to inactive ingredients in the drug substance and drug product or other monoclonal antibodies.\n24. Have any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the subject ability to sign the ICF, adversely affect the subject ability to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance\u002Falcohol abuse, in the opinion of the investigator.","MALE",{"count":191,"type":20},[50],"This is a multicenter, open-label, phase II study of YL201 in China to evaluate the efficacy, safety, and PK characteristics of YL201 on mCRPC.",[353],"Metastatic Castration-resistant Prostate Cancer (mCRPC)","2025-08-25",{"date":356,"type":31},"2025-08-27",{"date":358,"type":31},"2024-02-22",{"date":112,"type":20},{"name":37,"class":38},24,{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":369,"targetDuration":4,"studyType":21,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":67},"100564470","phase-3-a-phase-iii-study-of-yl201-in-recurrent-or-metastatic-nasopharyngeal-carcinoma-100564470","NCT06629597","A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma","A Randomized, Controlled, Multicenter Phase III Clinical Study of YL201 Versus Investigator's Choice of Chemotherapy in Subjects with Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Failed Prior PD-(L)1 Inhibitor and At Least Two Lines of Chemotherapy","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form (ICF).\n2. Aged ≥18 years and ≤75 years, male or female.\n3. ECOG performance status score of 0 or 1.\n4. Life expectancy ≥ 3 months.\n5. Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment.\n6. Have failed prior treatment with PD-(L)1 inhibitors and at least two lines of chemotherapy.\n7. Suitable for treatment with investigator's choice of chemotherapy (docetaxel, capecitabine, or gemcitabine).\n8. At least one measurable lesion according to RECIST v1.1.\n9. Subjects are willing to provide the archived or freshly obtained tumor tissue (freshly obtained or archived) for detection of B7-H3 expression\n10. Adequate organ function.\n\nExclusion Criteria:\n\n1. History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects who have been cured of other tumors by local therapy, such as basal cell carcinoma, squamous cell carcinoma of skin, bladder cancer in situ, cervical carcinoma in situ, or breast cancer in situ, are not excluded.\n2. Previously received B7-H3-targeted drug therapy, including antibody, antibody-drug conjugate (ADC), and chimeric antigen receptor T cell (CAR-T).\n3. Prior treatment with a topoisomerase I inhibitor or an antibody-drug conjugate containing a topoisomerase I inhibitor.\n4. Inadequate washout period for prior anti-tumor treatment before the first dose of study drug.\n5. Received radical radiotherapy within 4 weeks prior to the first dose of study drug; local palliative radiation for symptom control is allowed, but treatment must be completed at least 2 weeks prior to the first dose of study drug, and there is no plan for additional radiotherapy to the same lesion.\n6. Received systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.\n7. Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.\n8. Presence of brain stem or meningeal metastases, spinal cord metastases or compression.\n9. Presence of central nervous system (CNS) metastasis. Participants with treated brain metastases are eligible if the metastases are asymptomatic and stable, and no immediate local or systemic treatment is needed within 2 weeks before the first dose.\n10. Has an uncontrolled concurrent disease.\n11. Presence of severe uncontrolled cardiovascular disorder.\n12. History of interstitial lung disease (ILD) or pneumonitis that required corticosteroids, or current ILD\u002F pneumonitis.\n13. Concomitant pulmonary disorder leading to clinically severe respiratory impairment.\n14. Chronic autoimmune or inflammatory diseases requiring systemic therapy within 2 years prior to the first dose or currently receiving systemic therapy.\n15. Clinical symptoms of pleural effusion, pericardial effusion, or ascites or requiring relevant repeated drainage.\n16. Serious infections within 4 weeks prior to the first dose.\n17. Known active pulmonary tuberculosis (TB).\n18. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n19. Unresolved toxicities from previous antitumor therapy.\n20. Known allergy to any component of the study drug; history of severe allergic reactions or known history of severe hypersensitivity to other monoclonal antibodies or recombinant proteins, or history of severe infusion reactions.\n21. Pregnancy, breastfeeding, or women planning to become pregnant or breastfeed during the study.\n22. Any illness, medical condition, organ system dysfunction, or social situation deemed by the investigator to be likely to interfere with a subject's ability to sign ICF, adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study results.",{"count":370,"type":20},400,[126],"This study was designed to compare the efficacy and safety of YL201 with Investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma who have failed prior PD-(L)1 inhibitor and at least two lines of chemotherapy.",[374],"Nasopharyngeal Carcinoma","2025-02-06",{"date":377,"type":31},"2025-02-10",{"date":379,"type":31},"2024-12-31",{"date":381,"type":20},"2028-12-01",{"name":37,"class":38},{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":147,"minAge":17,"maxAge":122,"enrollmentInfo":390,"targetDuration":4,"studyType":21,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":67},"100549877","phase-2-a-phase-2-study-to-evaluate-the-efficacy-safety-and-pharmacokinetics-of-yl202-in-patients-with-bc-100549877","NCT06439771","A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC","A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With Locally Advanced or Metastatic Breast Cancer With TNBC, HR-Positive, HER2-Zero-expression or HER2-Low-expression","Inclusion Criteria:\n\n1. Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.\n2. Patients with locally advanced or metastatic disease (according to the UICC and AJCC staging system \\[Version 8\\]) who are not candidates for curative surgery or radiotherapy.\n3. Patients who are pathologically confirmed advanced\u002Funresectable or metastatic breast cancer with HR-negative and HER2-negative,.\n4. Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.\n5. Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC.\n6. Have at least 1 extracranial measurable lesion as a target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n7. Have Adequate organ and bone marrow function within 7 days prior to the first dose.\n8. Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.\n9. Have a expected survival ≥ 3 months.\n10. Have ability and willingness to comply with protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n1. Have prior treatment with an agent targeting HER3.\n2. Have prior intolerance to treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.\n3. Have been enrolled in another clinical study concurrently unless it is an observational clinical study or in the follow-up phase of an interventional study.\n4. Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.\n5. Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study.\n6. Have prior allogeneic bone marrow transplant or prior solid organ transplant.\n7. Have received treatment with systemic steroids.\n8. Have received any live vaccine within 4 weeks prior to the first dose of study drug or intend to receive a live vaccine during the study.\n9. Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.\n10. Brain metastases with the exceptions.\n11. Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.\n12. Have clinically significant concomitant pulmonary diseases.\n13. Have a diagnosis of Gilbert's syndrome.\n14. Have pleural effusion, abdominal effusion.\n15. Have a history of gastrointestinal perforation and or fistula within 6 months prior to the first dose.\n16. Have serious infection.\n17. Patients with human immunodeficiency virus (HIV) infection.\n18. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n19. Have any other primary malignancy within 5 years prior to the first dose of study drug.\n20. Have unresolved toxicities from prior anticancer therapy.\n21. Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.\n22. Lactating women, or women who are confirmed to be pregnant by pregnancy test within 3 days prior to the first dose.",{"count":391,"type":20},180,[50],"This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression",[153],"2024-11-13",{"date":397,"type":31},"2024-11-15",{"date":399,"type":31},"2024-04-23",{"date":401,"type":20},"2028-07-29",{"name":37,"class":38},""]