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

Официальное название

A Randomized, Open-label, Multi-center, Phase III Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Обзор

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.

Вмешательства

• Препарат MRG003 + Pucotenlimab
  MRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol.
• Препарат Gemcitabine, Docetaxel, or Capecitabine
  Gemcitabine will be administrated via intravenous infusion at 1000 mg/m2 once on Day 1 and 8 of every 3 weeks (21-day cycle). Docetaxel will be administrated via intravenous infusion at 75 mg/m2 once on Day 1 of every 3 weeks (21-day cycle). Capecitabine will be administrated orally at 1000 mg/m2 twice a day for Day 1 to 14 of every 3 weeks (21-day cycle).

Первичные конечные точки

• Progression Free Survival (PFS) as assessed by BIRC [Срок оценки: Baseline to study completion (up to 33 months)]
• Overall Survival (OS) [Срок оценки: Baseline to study completion (up to 48 months)]

Вторичные конечные точки (6)

• Objective Response Rate (ORR) [Срок оценки: Baseline to study completion (up to 48 months)]
• Disease Control Rate (DCR) [Срок оценки: Baseline to study completion (up to 48 months)]
• Progression Free Survival (PFS) as assessed by investigator [Срок оценки: Baseline to study completion (up to 33 months)]
• Immunogenicity (ADA) [Срок оценки: Baseline to 14 days after the last dose.]
• Adverse Events (AEs) [Срок оценки: Baseline to 30 days after the last dose of study treatment]
• Serious Adverse Events (SAEs) [Срок оценки: Baseline to 30 days after the last dose of study treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06976190 · HX008/MRG003-C002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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