NCT05126719

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma

An Open-Label, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Shanghai Miracogen Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with recurrent metastatic nasopharyngeal carcinoma.

Detailed description

The study consists of two stages. Part A of this study is an open-label, single arm, multicenter Phase IIa clinical study in patients with inoperable, radiotherapy ineligible RM-NPC who have failed (or are intolerable) at least 1 prior line platinum-based systemic chemotherapy and PD-1 (L1) inhibitors. Part B is an open-label, randomized, multicenter Phase IIb study to compare the efficacy and safety of MRG003 versus capecitabine/docetaxel in patients with RM-NPC who have failed at least 2 prior lines of systemic chemotherapy and PD-1 (L1) inhibitors.

Conditions

• Recurrent or Metastatic Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	MRG003	Administered intravenously
DRUG	Capecitabine tablets	Administered peros
DRUG	Docetaxel injection	Administered intravenously

Timeline

• Start date: 2023-04-06
• Primary completion: 2024-12-30
• Completion: 2026-12-30
• First posted: 2021-11-19
• Last updated: 2026-02-06

Locations

23 sites across 1 country: China