A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer
NCT06251973 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-05-15
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.
Conditions
- Metastatic Esophageal Carcinoma
- Advanced Unresectable Gastric Adenocarcinoma
- Metastatic Gastric Cancer
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Metastatic Esophageal Cancer
- Metastatic Esophageal Adenocarcinoma
- Metastatic Gastric Adenocarcinoma
- Metastatic Gastric Carcinoma
- Unresectable Esophageal Cancer
- Unresectable Esophageal Adenocarcinoma
- Unresectable Gastric Carcinoma
- Unresectable Gastric Adenocarcinoma
- Unresectable Gastroesophageal Junction Adenocarcinoma
Interventions
- BIOLOGICAL
-
AgenT-797
AgenT-797 is an investigational product, composed of allogeneic human unmodified iNKT cells, isolated from mononuclear cell aphaeresis units from healthy donors
- BIOLOGICAL
-
Botensilimab
Botensilimab is a novel, human, Fc-engineered IgG1 anti-CTLA-4 antibody
- DRUG
-
Balstilimab
Botensilimab is supplied as a sterile, single-use solution for IV administration
- DRUG
-
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.
- DRUG
-
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.
Sponsors & Collaborators
-
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Yelena Janjigian, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-01
- Primary Completion
- 2027-08-01
- Completion
- 2027-08-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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