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

Phase 1 Active, not recruiting NCT04535401

Condition	Advanced Colorectal Carcinoma, Advanced Digestive System Carcinoma, Advanced Gastric Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma
Phase	Phase 1
Sponsor	National Cancer Institute (NCI)
Status	Active, not recruiting
Enrollment	10 participants
Interventions	Biopsy, Biospecimen Collection, Diagnostic Imaging, Elimusertib, Fluorouracil
Start date	Aug 13, 2021
Completion date	Feb 19, 2025
Results posted	Jul 13, 2026

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.

Maximum Tolerated Dose (MTD) of Elimusertib (BAY 1895344) in Combination With Irinotecan, Fluorouracil, and Leucovorin (FOLFIRI)

Up to 28 days · mg/m2

Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)	NA mg/m2

Patients Who Experienced DLTs

Up to 28 days · percentage of patients

Treatment (Elimusertib, FOLFIRI): DL-1	33.3 percentage of patients
Treatment (Elimusertib, FOLFIRI): DL-1B	66.7 percentage of patients
Treatment (Elimusertib, FOLFIRI): DL1	33.3 percentage of patients
Treatment (Elimusertib, FOLFIRI): DL1B	100 percentage of patients

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Ad — Hoffmann-La Roche
Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patient — National Cancer Institute (NCI)
Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 — National Cancer Institute (NCI)
Study of Oxaliplatin and Xeloda and Cetuximab as First Line Treatment for Metastatic or Un — University of Southern California
Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresecta — National Cancer Institute (NCI)
Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients — National Cancer Institute (NCI)

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

English 한국어 日本語中文 Русский