A Phase II Study of agenT-797 (Invariant Natural Killer T Cells), Botensilimab, a Novel Fc-enhanced CTLA-4 Inhibitor, Plus Balstilimab (Anti-PD-1) With Ramucirumab and Paclitaxel for Patients With Previously Treated, Advanced Esophageal, Gastric, or Gastro-esophageal Junction Adenocarcinoma

Memorial Sloan Kettering Cancer Center14 个研究点分布在 1 个国家目标入组 20 人开始时间: 2024年2月1日最近更新: 2026年5月15日

适应症

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 20
试验地点: 14
主要终点: Overall Response Rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

Participants will receive study treatment with agenT-797, botensilimab, balstilimab, ramucirumab, and paclitaxel. When participants start each agent will depend on how their disease is affecting them.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Metastatic or advanced unresectable adenocarcinoma of esophageal, gastric, or gastroesophageal junction
•Disease progression on one prior line of therapy for metastatic disease. Patients with previously untreated advanced unresectable or metastatic disease may be included if disease progressed or recurred during neoadjuvant or adjuvant therapy or within 6 months of completion of those treatments.
•Patients must have histologically or cytologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma
•Patients must have measurable or evaluable disease as defined by RECIST v1.1 criteria. Patients with evaluable disease must be eligible to begin with an induction cycle
•Age 18 years or older
•ECOG performance status 0 to 1
•Adequate organ function as defined in Table 2
•Organ function requirements for eligibility Hematological Absolute neutrophil count: ≥1000/mcL Platelets: ≥90,000/mcL Hemoglobin: ≥8 g/dL Renal Serum creatinine: ≤1.5X ULN Hepatic Serum total bilirubin: ≤1.5X ULN OR Direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5X ULN, except patients with Gilbert's disease (≤3X ULN) AST and ALT: ≤2.5X ULN Albumin: ≥3 mg/dL

排除标准

•Received prior therapy with ramucirumab at any time
•Received paclitaxel or docetaxel-based therapy within 6 month of study enrollment
•Had a prior grade >3 immune related adverse event due to anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 therapy at any time
•Diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. Replacement therapy (ie physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic immunosuppressive therapy and is allowed.
•History of gastrointestinal perforation or fistulae
•A known history of active Bacillus tuberculosis
•Known active central nervous system metastases and/or carcinomatous meningitis
•History of or any evidence of active, non-infectious, immune-mediated pneumonitis. Patients with radiation-induced pneumonitis who are asymptomatic are permitted on study.
•Peripheral neuropathy limiting ADLs
•A known history of human immunodeficiency virus (HIV 1/2 antibodies)
•Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected). Patients with HBsAg reactive on entecavir may be eligible after consultation with hepatologist and study team.
•Received a live vaccine within 30 days of planned start of study therapy
•Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
•Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the prescreening or screening visit through 5 months after the last dose of trial treatment
•Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study