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MRG003's Efficacy and Safety in Recurrent Metastatic Nasopharyngeal Carcinoma

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Study Aim

This study aims to evaluate the safety and effectiveness of MRG003 in treating recurrent metastatic nasopharyngeal carcinoma, focusing on the objective response rate as assessed by an Independent Review Committee.

What is being tested

MRG003

+ Capecitabine tablets

+ Docetaxel injection

Drug
Who is being recruted

Nasopharyngeal Carcinoma+15

+ Carcinoma

+ Head and Neck Neoplasms

From 18 to 75 Years
+36 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2023
See protocol details

Summary

Principal SponsorShanghai Miracogen Inc.
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 6, 2023

Actual date on which the first participant was enrolled.

This clinical study focuses on evaluating the effectiveness and safety of a drug called MRG003 in treating patients with recurrent metastatic nasopharyngeal carcinoma, a type of cancer that affects the nasopharynx and has spread to other parts of the body. The study is particularly interested in helping patients who have not responded to or cannot tolerate previous treatments, including radiotherapy, platinum-based chemotherapy, and PD-1 (L1) inhibitors. The goal is to find a new treatment option that could improve care for these patients. The study is divided into two parts. In the first part, all participants will receive MRG003. In the second part, participants will be randomly assigned to receive either MRG003 or a combination of capecitabine and docetaxel, two commonly used chemotherapy drugs. The study will measure the response to treatment by looking at the proportion of patients who experience a complete or partial reduction in their tumors. This will be assessed by an Independent Review Committee using established cancer assessment guidelines (RECIST v1.1).

Official TitleAn Open-Label, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma
NCT05126719
Principal SponsorShanghai Miracogen Inc.
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

238 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nasopharyngeal CarcinomaCarcinomaHead and Neck NeoplasmsStomatognathic DiseasesNasopharyngeal DiseasesNasopharyngeal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPathologic ProcessesPharyngeal DiseasesPharyngeal NeoplasmsRecurrencePathological Conditions, Signs and SymptomsDisease Attributes

Criteria

12 inclusion criteria required to participate
Willing to sign the ICF and follow the requirements specified in the protocol.
Age: ≥18 years, ≤75 years
Expected survival time>3 months.
Patients with histologically confirmed unresectable, radiation-ineligible recurrent metastatic nasopharyngeal carcinoma.
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24 exclusion criteria prevent from participating
Grade ≥2 peripheral neuropathy per CTCAE v5.0.
Is expected to require surgery or any other form of systemic or local anti-tumor therapy during the study.
Received systemic chemotherapy, targeted therapy, biologics or immunotherapy, or major surgery (except for minor surgery within 2 weeks and fully recovered) within 3 weeks prior to the first dose of study treatment; received thoracic radiotherapy >30 Gy within 6 months prior to the first dose of study treatment; received prior radiotherapy (except radiotherapy for CNS, wash-out period ≥ 28 days is required) within 14 days before the first dose of study treatment, received traditional Chinese medicine with anti-tumor indications within the 2 weeks before the first dose of study treatment.
Known active central nervous system (CNS) metastases and/or meningeal metastases. Patients with brain metastases may participate provided they are treated and stable
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Part A: On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg or 2.3 mg/kg calculated based on the actual body weight. Part B: On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.3 mg/kg calculated based on the actual body weight.

Group II

Active Comparator
Part B: Capecitabine tablets: 1000 mg/m2, bid, d1-14, po, Q3W, or Docetaxel injection: 75 mg/m2, d1, IV, Q3W

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 23 locations

Suspended

Peking University Cancer Hospital

Beijing, ChinaOpen Peking University Cancer Hospital in Google Maps
Suspended

Chongqing University Cancer Hospital

Chongqing, China
Suspended

Fujian Cancer Hospital

Fuzhou, China
Suspended

Sun Yat-sen University Cancer Center

Guangzhou, China
Suspended23 Study Centers