Study on the Safety, Effectiveness, and Best Dose of ABBV-400 with Chemotherapy and Immunotherapy for Advanced Stomach and Esophageal Cancer

Sponsor: AbbVie

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06628310

Provider View

This clinical trial is testing a new treatment combination involving ABBV-400, chemotherapy drugs, and an immunotherapy drug, Budigalimab, to see if it is safe and effective for adults with advanced stomach or esophageal cancer that cannot be removed by surgery.

Patient Parameters

Program Overview

The study aims to find out if a new treatment combination, including ABBV-400, Fluorouracil, Leucovorin, and Budigalimab, is safe and can help control advanced stomach or esophageal cancer that cannot be surgically removed. ABBV-400 and Budigalimab are experimental drugs, while Fluorouracil and Leucovorin are already approved for this type of cancer. The study will have two parts: the first part will test increasing doses of ABBV-400 to find a safe and effective dose. In the second part, participants will be divided into groups to receive different treatment combinations to determine the best dose for future studies. Around 180 adults will participate in this study at 51 locations worldwide over approximately six years. Participants will have regular check-ups, including medical exams, blood tests, and questionnaires, to monitor the treatment's effects and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Have advanced stomach, gastroesophageal junction, or esophageal cancer that cannot be removed by surgery.
  • Have cancer that can be measured using standard criteria.
  • Be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have cancer that is negative for the HER2 marker.
  • Have known PD-L1 status or provide a tumor sample for testing before joining the study.

Exclusion Criteria

  • Have received previous treatment for advanced or metastatic cancer.
  • Have a history of significant lung-related illnesses.

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