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ACTIVE NOT RECRUITING
NCT04491942
PHASE1

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2021-08-25

Completion Date

2026-06-30

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Cisplatin

Given IV

DRUG

Elimusertib

Given PO

DRUG

Gemcitabine Hydrochloride

Given IV

Locations (8)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada