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Recruiting Phase 2 NCT06251973

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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Trial Parameters

Condition Metastatic Esophageal Carcinoma
Sponsor Memorial Sloan Kettering Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 37
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-02-01
Completion 2027-08-01
Interventions
AgenT-797BotensilimabBalstilimab

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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.

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

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