This phase I trial identifies the best dose, possible benefits and/or side effects of gemcitabine in combination with elimusertib (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. elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and elimusertib in combination may shrink or stabilize cancer.
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Incidence of adverse events
Timeframe: Up to 1 year
Maximum tolerated dose (MTD)
Timeframe: Up to completion of dose-escalation phase
Overall response rate (ORR) (expansion cohort)
Timeframe: Up to 1 year
Duration of response (expansion cohort)
Timeframe: Time at which measurement criteria are met for CR or PR (whichever is first recorded) until the first date on which recurrent or progressive disease is objectively documented, assessed up to 1 year
Progression free survival (PFS) (expansion cohort)
Timeframe: Time from study enrollment until the identification of disease progression or death, assessed up to 1 year
Overall survival (expansion cohort)
Timeframe: Time from study enrollment until death due to any cause, assessed up to 1 year