Trial Title:
A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer
NCT ID:
NCT06251973
Condition:
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
Conditions: Official terms:
Carcinoma
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Paclitaxel
Ramucirumab
Conditions: 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
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
AgenT-797
Description:
AgenT-797 is an investigational product, composed of allogeneic human unmodified iNKT
cells, isolated from mononuclear cell aphaeresis units from healthy donors
Arm group label:
Participants diagnoses with Esophageal, Gastric, or Gastro-esophageal Junction Cancer
Intervention type:
Biological
Intervention name:
Botensilimab
Description:
Botensilimab is a novel, human, Fc-engineered IgG1 anti-CTLA-4 antibody
Arm group label:
Participants diagnoses with Esophageal, Gastric, or Gastro-esophageal Junction Cancer
Intervention type:
Drug
Intervention name:
Balstilimab
Description:
Botensilimab is supplied as a sterile, single-use solution for IV administration
Arm group label:
Participants diagnoses with Esophageal, Gastric, or Gastro-esophageal Junction Cancer
Intervention type:
Drug
Intervention name:
Ramucirumab
Description:
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.
Arm group label:
Participants diagnoses with Esophageal, Gastric, or Gastro-esophageal Junction Cancer
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
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.
Arm group label:
Participants diagnoses with Esophageal, Gastric, or Gastro-esophageal Junction Cancer
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.
Criteria for eligibility:
Criteria:
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:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Y Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Start date:
February 1, 2024
Completion date:
August 1, 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06251973
http://www.mskcc.org
