A Study of YL201 in Patients With Advanced Solid Tumors

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). Part 1 will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available. Part 2 will include patients with selected advanced solid tumor types enrolled at the MTD/RED(s), to better define the safety profile and evaluate the efficacy of YL201.

NCT Number	NCT05434234
Lead Sponsor	MediLink Therapeutics (Suzhou) Co., Ltd.
Conditions	Advanced Solid Tumor
Enrollment	312 participants
Start Date	2022-05-25
Primary Completion	2027-04-06 (estimated)
Study Completion	2027-10-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-22