NCT06976190

A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

A Randomized, Open-label, Multi-center, Phase III Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 446 (estimated)
• Sponsor: Shanghai Miracogen Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multi-center, phase III study to evaluate the efficacy and safety, and immunogenicity of MRG003 in combination with pucotenlimab in patients with recurrent or metastatic nasopharyngeal carcinoma.

Conditions

• Recurrent or Metastatic Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	MRG003 + Pucotenlimab	MRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol.
DRUG	Gemcitabine, Docetaxel, or Capecitabine	Gemcitabine will be administrated via intravenous infusion at 1000 mg/m2 once on Day 1 and 8 of every 3 weeks (21-day cycle). Docetaxel will be administrated via intravenous infusion at 75 mg/m2 once on Day 1 of every 3 weeks (21-day cycle). Capecitabine will be administrated orally at 1000 mg/m2 twice a day for Day 1 to 14 of every 3 weeks (21-day cycle).

Timeline

• Start date: 2025-05-06
• Primary completion: 2029-05-01
• Completion: 2030-12-01
• First posted: 2025-05-16
• Last updated: 2026-01-20

Locations

1 site across 1 country: China