NCT06251973

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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	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	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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2024-02-09
• Last updated: 2025-12-02

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study