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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.
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
MRG003 + Pucotenlimab
MRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol.
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