CClinicalTrials.gg
Active, not recruitingNCT06251973Updated May 15, 2026

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 2 interventional study of AgenT-797 and Botensilimab in Metastatic Esophageal Carcinoma, Advanced Unresectable Gastric Adenocarcinoma and Metastatic Gastric Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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

Keywords

  • 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
  • 23-261
  • Memorial Sloan Kettering Cancer Center
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 20 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study 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.

    Biological: AgenT-797 · Biological: Botensilimab · Drug: Balstilimab · Drug: Ramucirumab · Drug: Paclitaxel

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.

06

What researchers measure

Primary outcomes

  1. Overall Response Rate

    Determine the efficacy of agenT-797, botensilimab and balstilimab in combination with ramucirumab and paclitaxel as second-line therapy in patients with advanced unresectable or metastatic esophagogastric cancer, as measured by ORR (defined as the percentage of patients who achieve either an objective complete response \[CR\] + partial response \[PR\])

    Time frame: up to 2 years

07

Study locations

7 sites
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
    Middletown, New Jersey 07748, United States
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey 07645, United States
  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activities)
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
    Harrison, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
    Uniondale, New York 11553, United States
08

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06251973
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Feb 9, 2024
Start date
Feb 1, 2024
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
May 15, 2026

Study contacts

Yelena Janjigian, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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