About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- MRG003 + Pucotenlimab
- Gemcitabine, Docetaxel, or Capecitabine