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
Shanghai Miracogen Inc.
446 participants
May 6, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria16
- 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
Interventions
MRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol.
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).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06976190