NCT07258979

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

A Multicenter, Open-label, Phase Ib/II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 Combined With Toripalimab, With or Without Cisplatin, in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, Phase Ib/II study conducted in China to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of YL201 combined with Toripalimab (doublet regimen) or YL201 combined with Toripalimab and Cisplatin (triplet regimen) in subjects with recurrent or metastatic nasopharyngeal carcinoma.

Conditions

• Recurrent or Metastatic Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	YL201	YL201 will be administered as an IV infusion
DRUG	Toripalimab	Toripalimab will be administered as an IV infusion
DRUG	Cisplatin	Cisplatin will be administered as an IV infusion

Timeline

• Start date: 2025-11-05
• Primary completion: 2028-02-01
• Completion: 2028-05-01
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

20 sites across 1 country: China