Status:
NOT_YET_RECRUITING
A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Lead Sponsor:
Shanghai Miracogen Inc.
Conditions:
Recurrent or Metastatic Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 metasta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT06976190
Start Date
May 1 2025
End Date
December 1 2030
Last Update
May 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060