RecruitingPhase 2NCT06251973

A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

37 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Gastric Adenocarcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Unresectable Gastric Adenocarcinoma Unresectable Gastroesophageal Junction Adenocarcinoma Metastatic Gastric Carcinoma Metastatic Gastric Cancer Metastatic Esophageal Carcinoma Unresectable Gastric Carcinoma Metastatic Esophageal Adenocarcinoma Unresectable Esophageal Adenocarcinoma Advanced Unresectable Gastric Adenocarcinoma Metastatic Esophageal Cancer Unresectable Esophageal Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three immunotherapy drugs — agenT-797, botensilimab, and balstilimab — in people with advanced stomach, esophageal, or gastroesophageal junction cancer. These drugs work by helping the immune system find and attack cancer cells. The trial is for people whose cancer has come back or worsened after prior treatment. **You may be eligible if...** - You are 18 or older with advanced or metastatic stomach, esophageal, or gastroesophageal junction adenocarcinoma - Your cancer has progressed on at least one prior line of treatment (or relapsed within 6 months of finishing earlier therapy) - You have measurable disease on imaging - You are generally in good health (ECOG performance status 0–1) - Your organs (liver, kidneys, bone marrow) are functioning adequately **You may NOT be eligible if...** - You have active brain metastases - You have certain autoimmune conditions requiring systemic treatment - You have had severe reactions to prior immunotherapy - Your general health status is poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAgenT-797

AgenT-797 is an investigational product, composed of allogeneic human unmodified iNKT cells, isolated from mononuclear cell aphaeresis units from healthy donors

BIOLOGICALBotensilimab

Botensilimab is a novel, human, Fc-engineered IgG1 anti-CTLA-4 antibody

DRUGBalstilimab

Botensilimab is supplied as a sterile, single-use solution for IV administration

DRUGRamucirumab

Ramucirumab is a fully human anti-VEGFR2 monoclonal IgG1 antibody (IgG1) that binds with high affinity to the extracellular domain of VEGFR2. Ramucirumab is a part of standard of care treatment for advanced gastric cancer or GEJ adenocarcinoma, after prior treatment with fluoropyrimidine- or platinum-containing chemotherarapy.

DRUGPaclitaxel

Paclitaxel is widely used across multiple cancer types and is a part of standard of care treatment for advanced EG adenocarcinoma after prior treatment with fluoropyrimidine- or platinum-containing chemotherarapy.