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

NCT06976190 | Recruiting Phase 3 DMC

• 1 other identifier: HX008/MRG003-C002
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 1

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

Keywords

MRG003; Pucotenlimab; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS) as assessed by BIRC

  PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

  Baseline to study completion (up to 33 months)

• Overall Survival (OS)

  OS is defined as the duration from the start of treatment to death of any cause.

  Baseline to study completion (up to 48 months)

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  Baseline to study completion (up to 48 months)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 48 months)

• Progression Free Survival (PFS) as assessed by investigator

  Baseline to study completion (up to 33 months)

• Immunogenicity (ADA)

  Baseline to 14 days after the last dose.

• Adverse Events (AEs)

  Baseline to 30 days after the last dose of study treatment

Study Arms (2)

MRG003 + Pucotenlimab

EXPERIMENTAL

Drug: MRG003 + Pucotenlimab

Chemotherapy Arm

ACTIVE COMPARATOR

Mono-chemotherapy as selected by investigator

Drug: Gemcitabine, Docetaxel, or Capecitabine

Interventions

MRG003 + Pucotenlimab DRUG

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

MRG003 + Pucotenlimab

Gemcitabine, Docetaxel, or Capecitabine 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).

Chemotherapy Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Nasopharyngeal Carcinoma

Interventions

Gemcitabine; Docetaxel; Capecitabine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ruihua Xu, M.D.

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)