drugset
drugset / Trial / NCT04491942

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

NCT04491942 ↗

Phase 1 Active not recruiting 74 enrolled National Cancer Institute (NCI)
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-08-25
Primary completion
2027-06-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified — Intravenous
Subject Elimusertib Small molecule — Oral
Subject Gemcitabine Small molecule — Intravenous

Indications

bile duct carcinoma carcinoma of esophagus cervical carcinoma endometrial carcinoma female breast carcinoma gastric carcinoma head and neck carcinoma intrahepatic bile duct cancer malignant pleural mesothelioma non-small cell lung carcinoma ovarian carcinoma penile carcinoma small cell lung carcinoma triple-negative breast carcinoma urothelial carcinoma