A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (Magic-C002)

Shanghai Miracogen

Status and phase

Enrolling

Phase 3

Conditions

Recurrent or Metastatic Nasopharyngeal Carcinoma

Treatments

Drug: MRG003 + Pucotenlimab

Drug: Gemcitabine, Docetaxel, or Capecitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06976190

HX008/MRG003-C002

Details and patient eligibility

About

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.

Enrollment

446 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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