NCT06976190 A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
| NCT ID | NCT06976190 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Miracogen Inc. |
| Condition | Recurrent or Metastatic Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 446 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 446 participants in total. It began in 2025-05-06 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Ruihua Xu, M.D.
PRINCIPAL INVESTIGATOR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT06976190 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Recurrent or Metastatic Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06976190 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 446 participants.
Is NCT06976190 currently recruiting?
Yes, NCT06976190 is actively recruiting participants. Contact the research team at clinicaltrials@miracogen.com.cn for enrollment information.
Where is the NCT06976190 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06976190 clinical trial?
NCT06976190 is sponsored by Shanghai Miracogen Inc.. The principal investigator is Ruihua Xu, M.D. at Sun Yat-Sen University Cancer Center. The trial plans to enroll 446 participants.