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ATR Inhibitor

BAY 1895344 + FOLFIRI for Stomach and Intestinal Cancer

Phase 1

Waitlist Available

Led By Liza C Villaruz

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 1

International normalization ratio (INR) =< 1.5 × ULN unless participant is receiving anticoagulant therapy, in which case prothrombin time (PT) or activated partial thromboplastin time (aPTT) should be within expected therapeutic range of anticoagulants. If patient has a new diagnosis of venous thromboembolism (VTE), then patient should be appropriately anticoagulated with low molecular weight heparin (LMWH) or direct acting oral anticoagulants (DOACs) and be clinically stable for at least 1 week post treatment onset

Must not have

Gastrointestinal pathology or history that adversely impact the ability to take or absorb oral medication

Patients with uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat stomach or intestinal cancer. The first drug, BAY 1895344, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The second drug, a chemotherapy drug called FOLFIRI, works 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. The trial is testing to see if the combination of these two drugs may help shrink advanced or metastatic stomach and/or intestinal cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include typical chemotherapy-related issues like fatigue, digestive problems, blood cell count changes, as well as potential drug-specific effects such as allergic reactions or enzyme inhibition that could affect cell growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My blood clotting levels are normal or managed if I'm on blood thinners.

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I am willing to have biopsies taken from my tumor for research.

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My kidney function, measured by GFR, is normal or near normal.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have any unmanaged ongoing illnesses.

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I am not on any strong medication that affects my liver enzyme levels, or I can switch them.

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I am not pregnant or breastfeeding.

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I have tolerated irinotecan treatment in the past.

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I have been treated with an ATR inhibitor before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD) of elimusertib (BAY 1895344) in combination with irinotecan, fluorouracil, and leucovorin (FOLFIRI)

Secondary study objectives

ATM status

AUC and Cmax of BAY 1895344

Area under curve (AUC) and concentration maximum (Cmax) of irinotecan and 5-FU

+5 more

Other study objectives

Incidence of adverse events

Status of deoxyribonucleic acid damage repair (DDR) genes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (elimusertib, FOLFIRI)Experimental Treatment7 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Leucovorin Calcium

2011

Completed Phase 3

~12500