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RECRUITING
NCT06976190
PHASE3

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

Sponsor: Shanghai Miracogen Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

446

Start Date

2025-05-06

Completion Date

2030-12

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

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).

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China