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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06251973
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AgenT-797 — BIOLOGICAL
    AgenT-797 is an investigational product, composed of allogeneic human unmodified iNKT cells, isolated from mononuclear cell aphaeresis units from healthy donors
  • Botensilimab — BIOLOGICAL
    Botensilimab is a novel, human, Fc-engineered IgG1 anti-CTLA-4 antibody
  • Balstilimab — DRUG
    Botensilimab is supplied as a sterile, single-use solution for IV administration
  • Ramucirumab — 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.
  • Paclitaxel — 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.

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
May 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants diagnoses with Esophageal, Gastric, or Gastro-esophageal Junction Cancer
    Participants with measurable disease and with evaluable disease as defined by RECIST v1.1 will be enrolled on this study.

Primary Outcome Measure

Overall Response Rate [ Time Frame: up to 2 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065-
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553-

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Limited protocol activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

Related Studies