A Phase 1, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

What this Trial Is About

Researchers are conducting a multicenter, open-label Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of YL211 in patients with advanced solid tumors. The study aims to determine the maximum tolerated dose MTD and recommended expansion doses RED of YL211, an antibody-drug conjugate, while assessing the nature and frequency of side effects and treatment responses in this patient group. The study includes three parts Part 1 involves dose escalation to assess safety and tolerability and establish MTD and RED. Part 2 is a backfill enrollment phase to further evaluate safety and efficacy at selected doses. Part 3 is a dose-expansion phase to continue evaluating safety and efficacy at the determined doses. YL211 is given to patients by intravenous infusion until treatment discontinuation criteria are met. Participants will undergo regular assessments including monitoring of adverse events, dose-limiting toxicities, and tumor response using RECIST version 1.1 criteria. Pharmacokinetic properties of YL211 and immune responses will also be measured. The study duration is approximately 36 months, with ongoing safety and efficacy evaluations throughout. Participants will be closely monitored for treatment effects and side effects during the study period and follow-up.

A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors