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
Public ClinicalTrials.gov record NCT04535401. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04535401
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 10 participants
Conditions and interventions
Conditions
- Advanced Colorectal Carcinoma
- Advanced Digestive System Carcinoma
- Advanced Gastric Carcinoma
- Advanced Gastroesophageal Junction Adenocarcinoma
- Clinical Stage III Gastric Cancer AJCC v8
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IV Gastric Cancer AJCC v8
- Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Metastatic Colorectal Carcinoma
- Metastatic Digestive System Carcinoma
- Metastatic Gastric Carcinoma
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Stage III Colorectal Cancer AJCC v8
- Stage IV Colorectal Cancer AJCC v8
Interventions
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Diagnostic Imaging Testing Procedure
- Elimusertib Drug
- Fluorouracil Drug
- Irinotecan Hydrochloride Drug
- Leucovorin Calcium Drug
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 12, 2021
- Primary completion
- Feb 18, 2025
- Completion
- Jun 30, 2027
- Last update posted
- Aug 20, 2026
2021 – 2027
United States locations
- U.S. sites
- 10
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| National Cancer Institute Developmental Therapeutics Clinic | Bethesda | Maryland | 20892 | — |
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | — |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04535401, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2026 · Synced Sep 4, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04535401 live on ClinicalTrials.gov.