Actively Recruiting
A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-12-02
37
Participants Needed
7
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic or advanced unresectable adenocarcinoma of esophageal, gastric, or gastroesophageal junction
- Disease progression on one prior line of therapy for metastatic disease or progression during/within 6 months after neoadjuvant or adjuvant therapy
- Histologically or cytologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma
- Measurable or evaluable disease as per RECIST v1.1 criteria
- Age 18 years or older
- ECOG performance status 0 to 1
- Adequate organ function including neutrophil count ≥1000/mcL, platelets ≥90,000/mcL, hemoglobin ≥8 g/dL, serum creatinine ≤1.5 times upper limit of normal, bilirubin ≤1.5 times upper limit of normal or direct bilirubin ≤ upper limit of normal if total bilirubin >1.5 times upper limit of normal (except Gilbert's disease), AST and ALT ≤2.5 times upper limit of normal, and albumin ≥3 mg/dL
You will not qualify if you...
- Prior therapy with ramucirumab at any time
- Paclitaxel or docetaxel-based therapy within 6 months before enrollment
- Previous grade >3 immune-related adverse event from anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 therapy
- Diagnosis of immunodeficiency or use of systemic steroid or immunosuppressive therapy within 7 days before first dose (except physiologic corticosteroid replacement)
- History of gastrointestinal perforation or fistulae
- Known active Bacillus tuberculosis infection
- Active central nervous system metastases or carcinomatous meningitis
- Active, non-infectious, immune-mediated pneumonitis (asymptomatic radiation-induced pneumonitis allowed)
- Peripheral neuropathy limiting activities of daily living
- Known HIV infection
- Active hepatitis B or C infection (with exceptions after consultation)
- Live vaccine within 30 days before starting study therapy
- Psychiatric or substance abuse disorders interfering with trial participation
- Pregnant, breastfeeding, or expecting to conceive or father children during study and for 5 months after last dose
- Unwilling or unable to provide informed consent or comply with study protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
Y
Yelena Janjigian, MD
CONTACT
G
Geoffrey Ku, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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