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

Официальное название

Becotatug Vedotin Plus Pucotenlimab as First-line Therapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial

Обзор

This study was designed to compare the efficacy and safety of Becotatug Vedotin (MRG003) combined with Pucotenlimab as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.

Вмешательства

• Препарат Becotatug Vedotin and Pucotenlimab
  Becotatug Vedotin (2.0mg/kg, ivgtt, every 3 weeks, D1) combined with Pucotenlimab (200mg, ivgtt, every 3 weeks, D1) is administered until disease progression (PD), unacceptable toxicity, or death.

Первичные конечные точки

• Progression Free Survival (PFS) [Срок оценки: Up to approximately 2 years.]

Вторичные конечные точки (5)

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 2 years.]
• The proportion of patients who achieved disease control [Срок оценки: Up to approximately 2 years.]
• Duration of Response (DoR) [Срок оценки: Up to approximately 2 years.]
• Overall Survival (OS) [Срок оценки: Up to approximately 2 years.]
• Incidence of adverse events [Срок оценки: Up to approximately 2 years.]

Критерии участия

Критерии включения

• Aged 18 to 75 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed nasopharyngeal carcinoma (NPC).
• Metastatic NPC (Stage IVB, AJCC 8th) or locally recurrent NPC unfit for curative local therapy (e.g., surgery, TACE, radiotherapy).
• Must be treatment-naive for recurrent or metastatic NPC.
• Must have ≥ 1 measurable lesions as defined per RECIST v1.1.
• Adequate organ function.
• For women of childbearing potential: negative pregnancy test within 7 days prior to treatment initiation. All participants of childbearing potential must agree to use effective contraception during the study and for 1 year after treatment discontinuation.
• Willing and able to provide written informed consent and comply with study procedures and follow-up visits.

Критерии исключения

• Peripheral neuropathy of Grade 2 or higher.
• Anticipated need for any other local or systemic anti-tumor therapy during the study period.
• 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.
• Active central nervous system (CNS) metastases or carcinomatous meningitis.
• 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).
• Severe or uncontrolled cardiovascular disease.
• History of or current interstitial lung disease, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, or symptomatic bronchospasm.
• Active infection requiring systemic therapy.
• Severe, or uncontrolled systematic diseases (e.g., uncontrolled hypertension, or uncontrolled diabetes).
• Known history of testing positive for human immunodeficiency virus (HIV).
• Known history of allogeneic hematopoietic stem cell, bone marrow, or solid organ transplantation.
• Known active hepatitis B or C infection, or other severe liver disease.
• Live vaccine within 30 days prior to the first dose.
• Residual toxicity from prior anti-tumor therapy higher than grade 1 (except alopecia, fatigue, and grade 2 hypothyroidism).
• 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.
• Known history of Grade 3 or higher hypersensitivity to any component of MRG003 or to other monoclonal antibodies.
• Uncontrolled pleural effusion, ascites, or pericardial effusion.
• 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.
• Any other condition that, in the opinion of the investigator, may compromise the safety and integrity of the study participant.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07381699 · WCH-2026-NPC-PII-MRG003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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