BAY 1895344 + FOLFIRI for Stomach and Intestinal Cancer

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4 substrates

Disqualifiers: ATR inhibitor, Uncontrolled illness, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 28 days per cycle

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial investigates the best dose, possible benefits and/or side effects of BAY 1895344 in combination with FOLFIRI in treating patients with stomach or intestinal cancer that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started (primary site) to other places in the body (metastatic). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan, fluorouracil, and leucovorin, (called FOLFIRI in short) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving BAY 1895344 in combination with FOLFIRI may help shrink advanced or metastatic stomach and/or intestinal cancer.

Research Team

Liza C. Villaruz

Principal Investigator

University of Pittsburgh Cancer Institute LAO

Eligibility Criteria

Adults with advanced or metastatic stomach/intestinal cancer who've progressed after first-line therapy can join. They must have adequate organ function, no severe reactions to similar drugs, and agree to use contraception. Those with certain viral infections must be stable on treatment without interactions.

Inclusion Criteria

Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN

Platelets >= 100,000/mcL

I am fully active or can carry out light work.

Exclusion Criteria

I have had cancer before, but it won't interfere with this study.

Patients with psychiatric illness/social situations that would limit compliance with study requirements

I have a stomach or intestine condition that affects how I absorb pills.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive elimusertib orally and FOLFIRI intravenously in 28-day cycles

28 days per cycle

Multiple visits per cycle for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Every 3 months

Treatment Details

Interventions

• BAY 1895344
• Fluorouracil
• Irinotecan Hydrochloride
• Leucovorin Calcium

Trial Overview The trial is testing BAY 1895344 combined with FOLFIRI chemotherapy against cancers of the stomach and intestines. It aims to find the best dose and assess benefits/side effects by seeing if this combination can shrink tumors more effectively than standard treatments.

Participant Groups

Group I: Treatment (elimusertib, FOLFIRI) Experimental Treatment 7 Interventions

Patients receive elimusertib PO QD on days 2, 3, 16, and 17 and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+