PRIMARY OBJECTIVES:~I. Evaluate the safety and tolerability of gemcitabine in combination with elimusertib (BAY 1895344), as assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. (Dose Escalation and Expansion Cohort) II. Determine the maximum tolerated dose (MTD) of gemcitabine in combination with BAY 1895344. (Dose Escalation Cohort)~SECONDARY OBJECTIVES:~I. To observe and record anti-tumor activity. II. Analyze the pharmacokinetic (PK) profile of the gemcitabine and BAY 1895344 combination.~III. Assessing whether immunohistochemical markers of deoxyribonucleic acid (DNA) damage, gamma-H2AX and phosphorylated (p)NBS1, increase in on-treatment biopsies compared to the levels seen in pre-treatment biopsies.~EXPLORATORY OBJECTIVES:~I. Explore biomarkers that predict response to this combination. II. Evaluate mechanisms of acquired resistance to this combination.~OUTLINE: This is a dose-escalation study of gemcitabine followed by a dose expansion study.~Patients receive gemcitabine intravenously (IV) over 30 minutes on days 1 and 8 and BAY 1895344 orally (PO) once daily (QD) or twice daily (BID) on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~After completion of study treatment, patients are followed up for 30 days.
This phase I trial identifies the best dose, possible benefits and/or side effects of gemcitabine in combination with BAY 1895344 in treating patients with pancreatic, ovarian, and other solid tumors that have spread to other places in the body (advanced). Gemcitabine is a chemotherapy drug that blocks the cell from making DNA and may kill tumor cells. BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and BAY 1895344 in combination may shrink or stabilize cancer.