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

NCT ID: NCT06976190

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 446 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-06
• Study Completion Date: 2030-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRG003 + Pucotenlimab

Group Type: EXPERIMENTAL

MRG003 + Pucotenlimab

Intervention Type: DRUG

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

Chemotherapy Arm

Mono-chemotherapy as selected by investigator

Group Type: ACTIVE_COMPARATOR

Gemcitabine, Docetaxel, or Capecitabine

Intervention Type: DRUG

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).

Interventions

MRG003 + Pucotenlimab

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

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Willing to sign the informed consent form and follow the requirements specified in the protocol.
• Life expectancy ≥ 12 weeks.
• Patients with histologically and cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) who have failed at least one line of prior systemic therapy.
• Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• The score of ECOG for performance status is 0 or 1.
• No severe cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%.
• Organ functions and coagulation function must meet the basic requirements.
• Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.

Exclusion Criteria

• History of hypersensitivity to any component of the investigational product.
• Received systemic chemotherapy, targeted therapy, biological therapy or immunotherapy for anti-tumor purpose, or major surgery within 3 weeks prior to the first dose of study treatment.
• Received anti-infection therapy within 2 weeks prior to the randomization
• Prior treatment with MMAE/MMAF ADC drugs
• Central nervous system metastasis.
• Poorly controlled systemic diseases
• Patients with poorly controlled heart diseases
• Poorly controlled pleural and peritoneal effusion or pericardial effusion
• ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
• Patients with prior ≥Grade 3 immuno-related adverse events (irAEs)
• Any clinically significant arteriovenous bleeding, pulmonary embolism, or deep venous thrombosis occurred within 3 months
• Received allogeneic tissue/solid organ transplantation.
• Inoculate live vaccine within 30 days before the first dose.
• Patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 180 days after the last dose of study treatment.
• History of other primary malignant tumor diseases.
• Other situations that are not suitable to participate a clinical trial per investigator's judgement

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Miracogen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruihua Xu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Program Director

Role: CONTACT

clinicaltrials@miracogen.com.cn

86-21-61637960

Facility Contacts

Ruihua Xu, M.D.

Role: primary

xurh@sysucc.org.cn

86-18127912775

Other Identifiers

HX008/MRG003-C002

Identifier Type: -

Identifier Source: org_study_id