Clinical trial · Interventional
A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With 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
NCT06976190CI-TRIAL-00124681Magic-C002recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Metastatic Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Docetaxel, or Capecitabine | Drug | — | UNRESOLVED |
| MRG003 + Pucotenlimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MRG003 + Pucotenlimab
- interventionNames
- Drug: MRG003 + Pucotenlimab
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy Arm
- description
- Mono-chemotherapy as selected by investigator
- interventionNames
- Drug: Gemcitabine, Docetaxel, or Capecitabine
Primary outcomes (2)
- measure
- Progression Free Survival (PFS) as assessed by BIRC
- timeFrame
- Baseline to study completion (up to 33 months)
- description
- PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.