Actively Recruiting
A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Led by Shanghai Miracogen Inc. · Updated on 2026-01-20
446
Participants Needed
1
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign the informed consent form and follow the protocol requirements
- Life expectancy of at least 12 weeks
- Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma
- Failed at least one prior systemic therapy
- At least one measurable lesion by RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- No severe cardiac dysfunction, with left ventricular ejection fraction at or above 50%
- Adequate organ and coagulation function
- Use of effective contraception during treatment and for 6 months after last dose for patients with childbearing potential
You will not qualify if you...
- History of hypersensitivity to any component of the study drugs
- Systemic chemotherapy, targeted therapy, biological therapy, immunotherapy, or major surgery within 3 weeks before first study treatment dose
- Anti-infection therapy within 2 weeks prior to randomization
- Prior treatment with MMAE/MMAF antibody-drug conjugates
- Central nervous system metastasis
- Poorly controlled systemic diseases or heart diseases
- Poorly controlled pleural, peritoneal, or pericardial effusion
- Grade 2 or higher toxic reaction or abnormal lab value from prior anti-tumor treatment
- Prior grade 3 or higher immune-related adverse events
- Significant bleeding, pulmonary embolism, or deep vein thrombosis within 3 months
- History of allogeneic tissue or solid organ transplant
- Live vaccine within 30 days before first dose
- Positive pregnancy test, breastfeeding, or refusal to use contraception during treatment and for 180 days after last dose
- History of other primary malignant tumors
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
P
Program Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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