A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Miracogen Inc.

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

Treatment groups

446 Participants
are divided into 2 treatment groups

Sponsors and collaborators