Phase I/Ib Trial of ATR Inhibitor BAY 1895344 in Combination with FOLFIRI in GI Malignancies with a Focus on Metastatic Colorectal and Gastric/Gastroesophageal Cancers


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This study is being done to answer the following question: What is the highest dose of BAY 1895344 and FOLFIRI chemotherapy (irinotecan, 5- fluorouracil, which is also known as 5-FU, and leucovorin) in combination that can be safely and tolerably taken in patients with advanced gastrointestinal cancer? This is the first time that these drugs will be tested together in humans. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your cancer. The usual approach is defined as care most people get for advanced gastrointestinal cancer. Please note that the study goal is to find a dose of the study drug, BAY 1895344, in combination with FOLFIRI chemotherapy where there is a one in four chance that a severe side effect occurs in the first 28 days of treatment with BAY 1895344.

Are you Eligible? (Inclusion Criteria)

  • Are you 18 years of age or older?
  • Do you have advanced or metastatic colon cancer and have progressed on at least one
  • prior treatment?
  • Are you able to make extra visits to the clinic for treatment and assessments?

Specialty Area(s)

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032