MRG003 plus pucotenlimab versus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma
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
This trial tests whether combining MRG003 with pucotenlimab works better than standard chemotherapy for people with recurrent or metastatic nasopharyngeal carcinoma who have had at least one prior systemic treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 446 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Miracogen Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, pucotenlimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06976190 on ClinicalTrials.gov |
What this trial studies
This randomized, open-label, phase III study enrolls patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least one prior systemic therapy and have measurable disease. Participants are assigned to receive either MRG003 plus the PD‑1 inhibitor pucotenlimab or investigator-choice chemotherapy (gemcitabine, docetaxel, or capecitabine). The trial will compare tumor response, safety, and immunogenicity using RECIST v1.1 criteria and standard toxicity assessments in patients with ECOG performance status 0–1. Key entry requirements include adequate organ and cardiac function, life expectancy of at least 12 weeks, and effective contraception for those with childbearing potential.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed recurrent or metastatic nasopharyngeal carcinoma who have failed at least one prior systemic therapy, have at least one measurable lesion, ECOG 0–1, adequate organ and cardiac function, and a life expectancy of 12 weeks or more.
Not a fit: Patients with uncontrolled cardiac disease, poor organ function, an ECOG performance status above 1, a history of hypersensitivity to the study drugs, or who do not meet the laboratory or contraception requirements are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the combination could improve response rates and prolong disease control compared with standard chemotherapy for patients with recurrent or metastatic NPC.
How similar studies have performed: Checkpoint inhibitors and antibody–drug conjugates have shown activity in nasopharyngeal carcinoma in earlier trials, but the specific combination of MRG003 and pucotenlimab remains relatively new with limited late-phase data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Ruihua Xu, M.D. — Sun Yat-Sen University Cancer Center
- Study coordinator: Program Director
- Email: clinicaltrials@miracogen.com.cn
- Phone: 86-21-61637960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.