Trial Profile

A Phase 1, Multicenter, Open-label, First-in-human Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer

Status: Active, no longer recruiting

Phase of Trial: Phase I

Latest Information Update: 29 Sep 2025

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At a glance

Drugs YL-202 (Primary)
Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer; Non-small cell lung cancer
Focus Adverse reactions; First in man
Sponsors MediLink Therapeutics

27 Aug 2025 Status changed from recruiting to active, no longer recruiting.
04 Nov 2024 According to BioNTech media release, On August 15, 2024, the FDA lifted the partial clinical hold that was placed on this trial, initially announced on June 17, 2024. Trial recruitment has been reinitiated with a focus on dose levels no higher than 3 mg/kg, where the safety profile was manageable and encouraging clinical activity was observed.
25 Sep 2024 Planned End Date changed from 1 Dec 2025 to 1 Dec 2026.

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