MRG003 Combined With Immunotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial

Exclusion Criteria

• •1. Peripheral neuropathy of Grade 2 or higher.
• •2. Anticipated need for any other local or systemic anti-tumor therapy during the study period.
• •3. Diagnosed and/or treated additional malignancy within 5 years of enrollment, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinoma.
• •4. Active central nervous system (CNS) metastases or carcinomatous meningitis.
• •5. Laboratory values within 7 days prior to enrollment falling outside specified eligibility ranges (e.g., Child-Pugh C; creatinine clearance \<30 mL/min; serum sodium \<135 mmol/L; serum potassium \<3.5 mmol/L).
• •6. Severe or uncontrolled cardiovascular disease.
• •7. History of or current interstitial lung disease, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, or symptomatic bronchospasm.
• •8. Active infection requiring systemic therapy.
• •9. Severe, or uncontrolled systematic diseases (e.g., uncontrolled hypertension, or uncontrolled diabetes).
• •10. Known history of testing positive for human immunodeficiency virus (HIV).
• •11. Known history of allogeneic hematopoietic stem cell, bone marrow, or solid organ transplantation.
• •12. Known active hepatitis B or C infection, or other severe liver disease.
• •13. Live vaccine within 30 days prior to the first dose.
• •14. Residual toxicity from prior anti-tumor therapy higher than grade 1 (except alopecia, fatigue, and grade 2 hypothyroidism).
• •15. Active autoimmune disease or a history of autoimmune disease requiring systemic steroid or immunosuppressive therapy. The following conditions are not exclusionary: mild asthma controlled with intermittent bronchodilators; stable hypothyroidism on hormone replacement; vitiligo; Graves' disease; or Hashimoto's disease.
• •16. Known history of Grade 3 or higher hypersensitivity to any component of MRG003 or to other monoclonal antibodies.
• •17. Uncontrolled pleural effusion, ascites, or pericardial effusion.
• •18. Pregnancy, breastfeeding, or unwillingness to use a highly effective method of contraception during the treatment period and for at least 180 days after the last dose.
• •19. Any other condition that, in the opinion of the investigator, may compromise the safety and integrity of the study participant.