A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Other Anti-Cancer Therapies in Patients with Advanced Solid Tumors

2025-523742-27-00 · tracked via the Priya Life Science EU tracker

Sponsor

Medilink Therapeutics (Suzhou) Co. Ltd.

Sponsor type

Pharmaceutical company

Therapeutic area

Neoplasms

Decision date

17/03/2026

Enrollment target

133

Sites

Poland, Spain, France, Romania, Italy, Belgium, Hungary, Germany

Condition studied

Advanced solid tumors

Investigational medicinal product(s)

YL201Tecentriq 1 200 mg concentrate for solution for infusion

Eligibility

Age group

65+ years, 18-64 years

Sex

Female, Male

Primary endpoint

Part 1 Primary Endpoints • AEs, laboratory abnormalities and DLTs, Part 2 Primary Endpoints • ORR: assessed using RECIST version 1.1 • PFS: assessed using RECIST version 1.1

Endpoint detail

Part 1: Secondary Endpoints • PK parameters • Incidence of anti-YL201 antibodies • ORR: assessed using RECIST version 1.1, Part 2: • AEs and laboratory abnormalities • PK parameters • Incidence of anti-YL201 antibodies • DOR: assessed using RECIST version 1.1 • OS

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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