Clinical Trial

A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors

Active, Not Recruiting Phase 1
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Summary
This is a phase 1, multicenter, open-label stydy to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy in Selected Subjects with Advanced Solid Tumors conducted in China. The study will include 2 parts: a dose escalation part (Part 1) followed by a cohort expansion part (Part 2). Part 1 will estimate the safety, tolerability and MTD/RED(s) of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors. Part 2 will estimate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-04-27; most recent amendment 2026-06-22.
Status change: Recruiting → Active, Not Recruiting 2026-06-22
Status change: Not Yet Recruiting → Recruiting 2024-07-19
Trial Details
NCT Number NCT06394414
Lead Sponsor MediLink Therapeutics (Suzhou) Co., Ltd.
Conditions Advanced Solid Tumors
Enrollment 187 participants
Start Date 2024-04-17
Primary Completion 2027-04-29 (estimated)
Study Completion 2030-04-29 (estimated)
Updated on ClinicalTrials.gov 2026-06-25