Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer
Public ClinicalTrials.gov record NCT04491942. 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
A Phase 1 Trial of the ATR Inhibitor BAY 1895344 in Combination With Cisplatin and With Cisplatin Plus Gemcitabine in Advanced Solid Tumors With an Emphasis on Urothelial Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I trial identifies the best dose, possible benefits and/or side effects of BAY 1895344 in combination with chemotherapy in treating patients with solid tumors or urothelial cancer that has spread to other places in the body (advanced). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cisplatin and gemcitabine are chemotherapy drugs that stop the growth of tumor cells by killing the cells. Combining BAY 1895344 with chemotherapy treatment (cisplatin, or cisplatin and gemcitabine) may be effective for the treatment of advanced solid tumors, including urothelial cancer.
Study identification
- NCT ID
- NCT04491942
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 74 participants
Conditions and interventions
Conditions
- Advanced Bile Duct Carcinoma
- Advanced Breast Carcinoma
- Advanced Cervical Carcinoma
- Advanced Endometrial Carcinoma
- Advanced Esophageal Carcinoma
- Advanced Gastric Carcinoma
- Advanced Head and Neck Carcinoma
- Advanced Lung Non-Small Cell Carcinoma
- Advanced Lung Small Cell Carcinoma
- Advanced Malignant Solid Neoplasm
- Advanced Ovarian Carcinoma
- Advanced Penile Carcinoma
- Advanced Pleural Malignant Mesothelioma
- Advanced Urothelial Carcinoma
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IV Breast Cancer AJCC v8
- Clinical Stage III Gastric Cancer AJCC v8
- Clinical Stage IV Gastric Cancer AJCC v8
- Stage III Cervical Cancer AJCC v8
- Stage III Distal Bile Duct Cancer AJCC v8
- Stage III Intrahepatic Bile Duct Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage III Penile Cancer AJCC v8
- Stage III Pleural Diffuse Malignant Mesothelioma AJCC v8
- Stage IV Cervical Cancer AJCC v8
- Stage IV Distal Bile Duct Cancer AJCC v8
- Stage IV Intrahepatic Bile Duct Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IV Penile Cancer AJCC v8
- Stage IV Pleural Diffuse Malignant Mesothelioma AJCC v8
- Triple-Negative Breast Carcinoma
- Unresectable Urothelial Carcinoma
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 24, 2021
- Primary completion
- Jun 29, 2027
- Completion
- Jun 29, 2027
- Last update posted
- Jul 30, 2026
2021 – 2027
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| National Cancer Institute Developmental Therapeutics Clinic | Bethesda | Maryland | 20892 | — |
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04491942, 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 Jul 30, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04491942 live on ClinicalTrials.gov.