Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines

Summary

This phase I trial investigates the best dose, possible benefits and/or side effects of BAY 1895344 in combination with FOLFIRI in treating patients with stomach or intestinal cancer that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started (primary site) to other places in the body (metastatic). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan, fluorouracil, and leucovorin, (called FOLFIRI in short) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving BAY 1895344 in combination with FOLFIRI may help shrink advanced or metastatic stomach and/or intestinal cancer.

Timeline

Start

2021-08-13

Primary completion

2025-02-19

Completion

2026-07-01

Publications

• Krishnamurthy A, Wang H, Rhee JC, Davar D, Moy RH, Ratner L, Christner SM, Holleran JL, Deppas J, Sclafani C, Schmitz JC, Gore S, Chu E, Bakkenist CJ, Beumer JH, Villaruz LC. Phase I trial of ATR inhibitor elimusertib with FOLFIRI in advanced or metastatic gastrointestinal malignancies (ETCTN 10406). Cancer Chemother Pharmacol. 2025 Jan 22;95(1):27. doi: 10.1007/s00280-024-04745-6.

Drugs

Indications