Phase II Study of YL202 to Assess Safety and Effectiveness in Adults With Advanced Solid Tumors Including NSCLC, Breast, Head and Neck, Colorectal, and Other Cancers

What this Trial Is About

Researchers are evaluating YL202 in a multicenter, open-label phase II study in China to understand its effects on patients with advanced solid tumors such as non-small cell lung cancer, breast cancer, head and neck squamous cell carcinoma, colorectal cancer, HER2-positive gastric cancer, cervical cancer, and ovarian cancer. The study aims to assess the efficacy, safety, and pharmacokinetic characteristics of YL202 in these patients. Patients will receive YL202 as an intravenous infusion, delivered as a lyophilized powder at a dose of 200 mg per vial. The treatment is given once every three weeks for locally advanced or metastatic tumors, with separate groups for different cancer types including NSCLC, breast cancer, HNSCC, and other locally advanced cancers. Each infusion lasts approximately 60 minutes. Participants will undergo evaluations including tumor response assessments according to RECIST v1.1 criteria, safety monitoring for adverse events, and pharmacokinetic analyses over approximately 36 months. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, and overall survival. Tumor tissue samples and other clinical data will also be collected to analyze treatment effects and biomarker relationships. Participants are expected to comply with scheduled visits and procedures throughout the study.

A Study of YL202 in Selected Patients With Advanced Solid Tumors