2025-523742-27-00招募中2 期
A Phase Ib/II, 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
Medilink Therapeutics (Suzhou) Co. Ltd.12 个研究点 分布在 5 个国家目标入组 51 人开始时间: 2026年3月5日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 12
- 主要终点
- Part 1 Primary Endpoints • AEs, laboratory abnormalities and DLTs
研究概览
简要总结
Part 1 Primary Objectives • To assess the safety of YL201 in combination with atezolizumab • To determine the maximum tolerated dose (MTD) for YL201 in combination with atezolizumab Part 2 Primary Objectives • To assess the anti-tumor activity of YL201 in combination with atezolizumab
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Capable of providing written informed consent.
- •18 years of age or older
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •Pathologically confirmed diagnosis of ES-SCLC
- •No prior systemic anti-cancer treatment
- •Have at least 1 evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •Adequate organ and bone marrow function
- •Life expectancy of ≥3 months
排除标准
- •Any prior targeting B7H3 treatments
- •Uncontrolled infection that requires systemic therapy
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •A history of severe hypersensitivity reactions to drug substances, inactive ingredients in the drug product, or other mAbs
- •Any prior therapy with TOP1 inhibitors or ADCs composed of TOP1 inhibitors
- •Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study
- •Symptomatic or actively progressing brain metastases
- •Active or prior documented autoimmune, inflammatory disorders, or immune deficiency, autoimmune pneumonitis, and autoimmune myocarditis
- •Received any live vaccine within 4 weeks before the first dose of study drug
- •Received systemic steroids or other immunosuppressive therapy within 2 weeks prior to initiation of study treatment
- •Clinically significant concomitant pulmonary disease
- •Uncontrolled or clinically significant cardiovascular disease
研究组 & 干预措施
YL201
Test
干预措施: YL201 (Drug)
Tecentriq 1 200 mg concentrate for solution for infusion
Test
干预措施: Tecentriq 1 200 mg concentrate for solution for infusion (Drug)
结局指标
主要结局
Part 1 Primary Endpoints • AEs, laboratory abnormalities and DLTs
Part 1 Primary Endpoints • AEs, laboratory abnormalities and DLTs
Part 2 Primary Endpoints • ORR: assessed using RECIST version 1.1 • PFS: assessed using RECIST version 1.1
Part 2 Primary Endpoints • ORR: assessed using RECIST version 1.1 • PFS: assessed using RECIST version 1.1
次要结局
- Part 1: Secondary Endpoints • PK parameters • Incidence of anti-YL201 antibodies • ORR: assessed using RECIST version 1.1
- Part 2: • AEs and laboratory abnormalities • PK parameters • Incidence of anti-YL201 antibodies • DOR: assessed using RECIST version 1.1 • OS
研究者
Medilink Therapeutics
Scientific
Medilink Therapeutics (Suzhou) Co. Ltd.
研究点 (12)
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