Clinical Trial

A Study YL201 in Patients With Selected Advanced Solid Tumors

Active, Not Recruiting Phase 1/2
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Summary
This is A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients with Selected Advanced Solid Tumors. The study will include 2 parts: Phase 1 dose expansion stage (Part 1) followed by a Phase 2 stage with expanded sample size (Part 2). Part 1 will estimate the RP2D in dose expansion cohorts of patients with not linited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), nasopharyngeal carcinoma (NPC), esophageal squamous cell carcinoma (ESCC), metastatic castration-resistant prostate cancer (mCRPC), head and neck squamous cell carcinoma (HNSCC), sarcoma, ductal adenocarcinoma of pancreas (PDAC), hepatocellular carcinoma (HCC), biliary tract cancer (BTC), etc.. Part 2 will include patients with selected advanced solid tumor types enrolled at the RP2D to further assess the efficacy and safety of YL201.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-09-21; most recent amendment 2026-03-11.
Status change: Recruiting → Active, Not Recruiting 2026-03-11
Trial Details
NCT Number NCT06057922
Lead Sponsor MediLink Therapeutics (Suzhou) Co., Ltd.
Conditions Advanced Solid Tumor
Enrollment 990 participants
Start Date 2023-09-22
Primary Completion 2026-10 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-12