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
Study identification
- NCT ID
- NCT04535401
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- National Cancer Institute (NCI)
- NIH
- 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
- Biospecimen Collection Procedure
- Diagnostic Imaging 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
- Mar 28, 2024
- Completion
- Apr 28, 2025
- Last update posted
- Oct 9, 2024
2021 – 2025
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 | — |
| University of Pittsburgh Cancer Institute (UPCI) | 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 Oct 9, 2024 · Synced May 19, 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.