Study Evaluating Safety and Dose of YL201 Combined with Atezolizumab for Advanced Solid Tumors Including Small Cell Lung Cancer

What this Trial Is About

Researchers are studying the combination of YL201 and atezolizumab in adults with extensive-stage small cell lung cancer ES-SCLC and other advanced solid tumors. This phase IbII, multicenter, open-label trial has two parts the first part focuses on dose escalation to assess safety and tolerability, while the second part includes dose optimization with randomization and dose expansion based on safety and efficacy data. The study aims to find the best dose of YL201 combined with a fixed dose of atezolizumab. Participants receive YL201 through intravenous infusion on Day 1 of each 21-day cycle at one of three dose levels 1.2 mgkg, 1.6 mgkg, or 2.0 mgkg combined with 1200 mg of atezolizumab given intravenously on the same schedule. The studys dose optimization stage randomly assigns participants to one of the YL201 dose groups, and treatment continues until disease progression, unacceptable side effects, or withdrawal of consent. Dose expansion will follow, selecting one or two doses based on earlier findings. During the study, participants undergo monitoring for safety, including dose-limiting toxicities over 21 days and adverse events throughout treatment or until death up to about 6 years. Researchers will also assess tumor response, duration of response, progression-free survival, overall survival, and drug pharmacokinetics for up to 3 years. The total study duration extends until February 2029, with regular evaluations to track treatment effects and participant health.

A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors