Experimental drug combo targets Hard-to-Treat cancers

NCT ID NCT04491942

First seen Nov 01, 2025 · Last updated Jun 22, 2026 · Updated 45 times

Summary

This early-phase trial tests an experimental drug called BAY 1895344 combined with standard chemotherapy (cisplatin, with or without gemcitabine) in people with advanced solid tumors, especially urothelial cancer. The goal is to find the best dose and see how safe the combination is. About 74 participants will be enrolled.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

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

    New York, New York, 10032, United States

  • National Cancer Institute Developmental Therapeutics Clinic

    Bethesda, Maryland, 20892, United States

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

BAY 1895344 (an experimental drug that blocks a protein called ATR, which cancer cells need to grow) combined with chemotherapy drugs cisplatin and gemcitabine

What this could lead to

If this works, it could point toward a new treatment option for advanced solid tumors, especially urothelial cancer, by making chemotherapy more effective.

What could go wrong

This is an early phase 1 trial with only 74 participants, so it is mainly looking for the right dose and safety. It may not show clear benefit, and combining drugs can increase side effects.

Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma cancer cervical cancer cervical carcinoma gastric cancer gastric carcinoma lung neoplasm malignant pleural mesothelioma Mesothelioma, Malignant ovarian cancer ovarian carcinoma penile neoplasm triple-negative breast carcinoma urothelial carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED BILE DUCT CARCINOMA ADVANCED BREAST CARCINOMA ADVANCED CERVICAL CARCINOMA ADVANCED ENDOMETRIAL 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 III BREAST CANCER AJCC V8 ANATOMIC STAGE IV BREAST CANCER AJCC V8 CLINICAL STAGE III GASTRIC CANCER AJCC V8 CLINICAL STAGE III GASTRIC CANCER AJCC V8 CLINICAL STAGE IV GASTRIC CANCER AJCC V8 CLINICAL STAGE IV GASTRIC CANCER AJCC V8 STAGE III CERVICAL CANCER AJCC V8 STAGE III CERVICAL CANCER AJCC V8 STAGE III DISTAL BILE DUCT CANCER AJCC V8 STAGE III DISTAL BILE DUCT CANCER AJCC V8 STAGE III INTRAHEPATIC BILE DUCT CANCER AJCC V8 STAGE III INTRAHEPATIC BILE DUCT CANCER AJCC V8 STAGE III LUNG CANCER AJCC V8 STAGE III LUNG CANCER AJCC V8 STAGE III OVARIAN CANCER AJCC V8 STAGE III OVARIAN CANCER AJCC V8 STAGE III PENILE CANCER AJCC V8 STAGE III PENILE CANCER AJCC V8 STAGE III PLEURAL DIFFUSE MALIGNANT MESOTHELIOMA AJCC V8 STAGE III PLEURAL DIFFUSE MALIGNANT MESOTHELIOMA AJCC V8 STAGE III PLEURAL MALIGNANT MESOTHELIOMA AJCC V8 STAGE IV CERVICAL CANCER AJCC V8 STAGE IV CERVICAL CANCER AJCC V8 STAGE IV DISTAL BILE DUCT CANCER AJCC V8 STAGE IV DISTAL BILE DUCT CANCER AJCC V8 STAGE IV INTRAHEPATIC BILE DUCT CANCER AJCC V8 STAGE IV INTRAHEPATIC BILE DUCT CANCER AJCC V8 STAGE IV LUNG CANCER AJCC V8 STAGE IV LUNG CANCER AJCC V8 STAGE IV OVARIAN CANCER AJCC V8 STAGE IV OVARIAN CANCER AJCC V8 STAGE IV PENILE CANCER AJCC V8 STAGE IV PENILE CANCER AJCC V8 STAGE IV PLEURAL DIFFUSE MALIGNANT MESOTHELIOMA AJCC V8 STAGE IV PLEURAL DIFFUSE MALIGNANT MESOTHELIOMA AJCC V8 STAGE IV PLEURAL MALIGNANT MESOTHELIOMA AJCC V8 TRIPLE-NEGATIVE BREAST CARCINOMA UNRESECTABLE UROTHELIAL CARCINOMA