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

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ClinicalTrials.gov Identifier: NCT06251973

Recruitment Status : Recruiting

First Posted : February 9, 2024

Last Update Posted : April 5, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center

Tracking Information

First Submitted Date ^ICMJE

February 1, 2024

First Posted Date ^ICMJE

February 9, 2024

Last Update Posted Date

April 5, 2024

Actual Study Start Date ^ICMJE

February 1, 2024

Estimated Primary Completion Date

August 1, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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])

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

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.

Study Arms ^ICMJE

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.

Interventions:

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

August 1, 2027

Estimated Primary Completion Date

August 1, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 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:

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 pneumonitis
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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Yelena Janjigian, MD	646-888-4186	janjigiy@mskcc.org
Contact: Geoffrey Ku, MD	646-888-4588	kug@mskcc.org

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT06251973

Other Study ID Numbers ^ICMJE

23-361

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Yes

Plan Description:

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.

Current Responsible Party

Memorial Sloan Kettering Cancer Center

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Memorial Sloan Kettering Cancer Center

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Yelena Janjigian, MD

Memorial Sloan Kettering Cancer Center

PRS Account

Memorial Sloan Kettering Cancer Center

Verification Date

April 2024

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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