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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Enrolling

Phase 2

Conditions

Metastatic Esophageal Carcinoma

Metastatic Esophageal Cancer

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic Gastric Carcinoma

Unresectable Gastroesophageal Junction Adenocarcinoma

Advanced Unresectable Gastric Adenocarcinoma

Unresectable Gastric Adenocarcinoma

Metastatic Gastric Adenocarcinoma

Unresectable Esophageal Adenocarcinoma

Metastatic Esophageal Adenocarcinoma

Metastatic Gastric Cancer

Unresectable Gastric Carcinoma

Unresectable Esophageal Cancer

Treatments

Drug: Balstilimab

Biological: AgenT-797

Drug: Ramucirumab

Drug: Paclitaxel

Biological: Botensilimab

Study type

Interventional

Funder types

Other

Identifiers

NCT06251973

23-361

Details and patient eligibility

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.

Enrollment

37 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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