NCT05434234

A Study of YL201 in Patients With Advanced Solid Tumors

A Phase 1A/1B, Multicenter, Nonrandomized, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL201 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	YL201	Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle.
DRUG	YL201	Patients will be treated with YL201 intravenous (IV) (A mg/kg or B g/kg infusion once every 3 weeks (Q3W) as a cycle.
DRUG	YL201 and atezolizumab	Patients will be treated with YL201 intravenous (IV) infusion (A mg/kg or B mg/kg, up to 200mg) followed by atezolizumab on day 1 of each 21 day cycle

Timeline

• Start date: 2022-05-25
• Primary completion: 2027-04-06
• Completion: 2027-10-06
• First posted: 2022-06-27
• Last updated: 2025-11-10

Locations

45 sites across 6 countries: United States, Canada, China, France, Poland, Spain

Regulatory

• FDA-regulated drug study