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

Inclusion Criteria:

• Willing to sign the informed consent form and follow the requirements specified inthe protocol.

• Life expectancy ≥ 12 weeks.

• Patients with histologically and cytologically confirmed recurrent or metastaticnasopharyngeal carcinoma (NPC) who have failed at least one line of prior systemictherapy.

• Patients must have at least one measurable lesion according to the ResponseEvaluation 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 thetreatment 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 orimmunotherapy for anti-tumor purpose, or major surgery within 3 weeks prior to thefirst 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 previousanti-tumor treatment

• Patients with prior ≥Grade 3 immuno-related adverse events (irAEs)

• Any clinically significant arteriovenous bleeding, pulmonary embolism, or deepvenous 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 donot agree to take adequate contraceptive measures during the treatment and for 180days 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 perinvestigator's judgement