Study on Combination Therapy for Esophageal, Gastric, or Gastro-esophageal Junction Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06251973

Provider View

This clinical trial is testing a combination of five different drugs to see if they can help treat people with esophageal, gastric, or gastro-esophageal junction cancer. The timing of when each drug is given will depend on how the cancer is affecting the participant.

Patient Parameters

Program Overview

Participants in this study will receive a combination of five drugs: agenT-797, botensilimab, balstilimab, ramucirumab, and paclitaxel. The study aims to find out if this combination can effectively treat esophageal, gastric, or gastro-esophageal junction cancer. The order and timing of the drugs will be adjusted based on each participant's condition.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic esophageal, gastric, or gastroesophageal junction cancer that cannot be removed by surgery.
  • The cancer must have worsened after one previous treatment for metastatic disease, or if untreated, it must have progressed during or shortly after initial treatments.
  • Must have a confirmed diagnosis of esophageal, gastric, or gastroesophageal junction adenocarcinoma through lab tests.
  • Must have cancer that can be measured or evaluated using standard criteria.
  • Must be 18 years or older.
  • Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate organ function, including:
    • Neutrophil count of at least 1000/mcL.
    • Platelet count of at least 90,000/mcL.
    • Hemoglobin level of at least 8 g/dL.
    • Serum creatinine level no more than 1.5 times the upper limit of normal.
    • Liver function tests within specified limits, except for certain conditions like Gilbert's disease.
    • Albumin level of at least 3 mg/dL.

Exclusion Criteria

  • Have previously received ramucirumab.
  • Have received paclitaxel or docetaxel-based therapy within 6 months before joining the study.
  • Have had severe immune-related side effects from certain cancer therapies.
  • Have an immune deficiency or are taking immune-suppressing medications, except for specific replacement therapies.
  • Have a history of gastrointestinal perforation or fistulae.
  • Have active tuberculosis.
  • Have active cancer spread to the brain or spinal cord.
  • Have a history of lung inflammation not caused by infection.
  • Have nerve damage affecting daily activities.
  • Have HIV or active hepatitis B or C infections.
  • Have received a live vaccine within 30 days before starting the study.
  • Have psychiatric or substance abuse issues that would interfere with the study.
  • Are pregnant, breastfeeding, or planning to have children during the study and for 5 months after.
  • Are unwilling to provide informed consent or unable to follow the study requirements.

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