Study of YL201 Combined With Toripalimab, With or Without Cisplatin, for Treating Recurrent or Metastatic Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and how the body processes a drug called YL201 when combined with Toripalimab, either with or without Cisplatin, in adults with recurrent or metastatic nasopharyngeal carcinoma. This open-label Phase IbII trial is conducted across multiple centers in China and focuses on patients whose cancer cannot be cured with local treatment. The study aims to better understand treatment effects in this advanced cancer setting. Treatment involves two groups one receiving YL201 plus Toripalimab and another receiving YL201 plus Toripalimab and Cisplatin. All study drugs are given by intravenous infusion. The trial includes a dose exploration phase to assess safety and efficacy of these combinations. Participants receive treatment according to randomized assignment to one of these regimens. Participants will be monitored for side effects, cancer progression, and response to treatment over about 36 months. Researchers will assess dose-limiting toxicities, treatment-emergent adverse events, progression-free survival, and other measures such as response rate and overall survival. The study also evaluates how YL201 and its metabolites behave in the body. Participants will undergo regular medical exams, imaging, and lab tests during the study period to track outcomes and safety.

A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.