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

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 metastatic nasopharyngeal carcinoma.

Eligibility

Inclusion Criteria:

* 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 Criteria:

* 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

Conditions2

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