BAY 1895344 + Chemotherapy for Bladder Cancer

Recruiting at9 trial locations

Overseen by Mamta Parikh

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, BAY 1895344, combined with chemotherapy to treat advanced cancers. It aims to find the best dose and check for side effects. The treatment works by blocking enzymes needed for tumor growth and killing cancer cells. The trial focuses on patients with advanced solid tumors or urothelial cancer.

Research Team

Mamta Parikh

Principal Investigator

City of Hope Comprehensive Cancer Center LAO

Eligibility Criteria

Adults with advanced solid tumors or urothelial cancer, including those HIV-positive on effective therapy, and those who've had certain prior treatments. Must have adequate organ function and not be pregnant or breastfeeding. Excludes individuals with significant neuropathy, hearing loss, recent chemotherapy/radiotherapy, other active cancers needing treatment (except some skin/prostate cancers), or psychiatric/social conditions affecting compliance.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

Your hemoglobin level is at least 9 grams per deciliter.

I have previously received immune checkpoint inhibitor therapy.

Exclusion Criteria

I am not on any strong medication that affects liver enzymes or can't switch to another.

I haven't had chemotherapy, radiotherapy, or targeted therapies like PARP inhibitors in the specified time before joining the study.

The doctor thinks you have less than 6 weeks to live.

Treatment Details

Interventions

• BAY 1895344 (Enzyme Inhibitor)
• Cisplatin (Alkylating Agent)
• Gemcitabine Hydrochloride (Anti-metabolite)

Trial Overview The trial is testing BAY 1895344 added to usual chemotherapy drugs Cisplatin or Cisplatin plus Gemcitabine for treating advanced solid tumors. It aims to find the best dose of BAY 1895344 and assess its benefits/side effects when combined with these chemotherapies.

Participant Groups

Group I: Arm II (cisplatin, gemcitabine, elimusertib) Experimental Treatment 3 Interventions

Patients receive cisplatin IV over 1-2 hours on day 1 and 8, gemcitabine IV over 30 minutes on days 1 and 8, and elimusertib PO QD on days 2 and 9. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (cisplatin, elimusertib) Experimental Treatment 2 Interventions

Patients receive cisplatin IV over 1-2 hours on day 1 and 8, and elimusertib PO QD on days 2 and 9. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School