Phase 12 Study of YL201 to Evaluate Safety and Effectiveness in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are conducting a phase 1, multicenter, nonrandomized, open-label study to evaluate YL201 in patients with advanced solid tumors that have not responded to current treatments or lack standard therapy options. The study includes two parts Part 1 focuses on finding the maximum tolerated dose and recommended dose levels through dose escalation, while Part 2 enrolls patients with selected tumor types to further assess safety and efficacy of YL201. Participants will receive YL201 as an intravenous infusion once every three weeks in cycles. Some patients may receive YL201 alone at different dosages or in combination with atezolizumab during each 21-day cycle. Part 1 involves dose escalation cohorts to determine appropriate dosing, followed by Part 2 dose expansion cohorts to better define safety and evaluate treatment responses. Throughout the study, participants undergo tumor evaluations using RECIST criteria, laboratory tests, and safety monitoring to track adverse events, dose-limiting toxicities, and pharmacokinetics. For prostate cancer patients, prostate-specific antigen response and progression-free survival will be measured. The study lasts approximately 36 months, with ongoing assessments of tumor response, survival, and laboratory abnormalities conducted at regular intervals.

A Study of YL201 in Patients With Advanced Solid Tumors