Actively Recruiting
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
Led by Shanghai Miracogen Inc. · Updated on 2026-01-20
446
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of MRG003 and pucotenlimab compared to chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma. This phase III, randomized, open-label, multi-center study aims to assess the effectiveness, safety, and immune response of these treatments in patients who have already undergone at least one systemic therapy. The study is sponsored by Shanghai Miracogen Inc. and focuses on improving outcomes for patients with this type of cancer. Participants will be assigned randomly to one of two groups: one receiving MRG003 combined with pucotenlimab, and the other receiving one of the chemotherapy drugs gemcitabine, docetaxel, or capecitabine as chosen by the investigator. MRG003 and pucotenlimab will be given according to the study protocol. Chemotherapy drugs are given either by intravenous infusion or orally on specific schedules within 21-day cycles. The study treatment period can last up to 48 months with ongoing assessments. During the study, participants will undergo evaluations including imaging to measure tumor response, laboratory tests, and monitoring of side effects from baseline through study completion. Researchers will track progression-free survival, overall survival, response rates, and immune reactions. Safety will be monitored up to 30 days after the last dose. The total duration of participation may last up to about four years, including follow-up to observe long-term outcomes and adverse events.
CONDITIONS
Brief 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 and cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma
- Failed at least one prior systemic therapy
- At least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- No severe cardiac dysfunction, with left ventricular ejection fraction above 50%
- Adequate organ and coagulation function
- Use of effective contraception during treatment and for 6 months after last dose if of childbearing potential
You will not qualify if you...
- History of hypersensitivity to any component of the investigational product
- Received systemic chemotherapy, targeted therapy, biologic therapy, immunotherapy, or major surgery within 3 weeks before first study dose
- Received anti-infection therapy within 2 weeks prior to randomization
- Prior treatment with MMAE/MMAF antibody-drug conjugates
- Presence of central nervous system metastasis
- Poorly controlled systemic diseases or heart diseases
- Poorly controlled pleural, peritoneal, or pericardial effusion
- Grade 2 or higher toxic reactions or lab abnormalities from previous anti-tumor treatment
- Prior grade 3 or higher immune-related adverse events
- Significant bleeding events, pulmonary embolism, or deep vein thrombosis within 3 months
- Received allogeneic tissue or organ transplantation
- Live vaccine within 30 days before first dose
- Positive pregnancy test, breastfeeding, or refusal to use adequate contraception during and 180 days after treatment
- History of other primary malignant tumors
- Any condition deemed unsuitable for clinical trial participation by investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 33 months until disease progression or discontinuation
Participants receive either the combination of MRG003 and Pucotenlimab or chemotherapy as selected by the investigator.
Visits every 3 weeks for treatment administration and monitoring
Duration - Up to 48 months
Participants are monitored for overall survival and safety for up to 48 months from baseline, including adverse events after treatment ends.
Periodic visits for survival and safety assessments
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
P
Program Director
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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