NCT07381699尚未招募2 期
Becotatug Vedotin Plus Pucotenlimab as First-line Therapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
MRG003 + PD-1 inhibitor
Experimental
Subjects receive becotatug vedotin plus pucotenlimab
干预措施: Becotatug Vedotin and Pucotenlimab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to approximately 2 years.
Defined as the period from treatment initiation until disease progression or death from any cause, whichever occurs first.
次要结局
- Objective Response Rate (ORR)(Up to approximately 2 years.)
- The proportion of patients who achieved disease control(Up to approximately 2 years.)
- Duration of Response (DoR)(Up to approximately 2 years.)
- Overall Survival (OS)(Up to approximately 2 years.)
- Incidence of adverse events(Up to approximately 2 years.)
研究者
Lei Liu
Director of head and neck oncology Department
West China Hospital
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