Elimusertib + Chemotherapy for Pancreatic and Ovarian Cancer

Palo Alto (17 mi)

Overseen byJames M Cleary

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 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.

Eligibility Criteria

Adults with advanced pancreatic, ovarian, or other solid tumors that have spread and are not curable by standard treatments. Participants must have measurable disease, may have had prior gemcitabine treatment, and should not exceed two lines of cytotoxic chemotherapy. HIV-positive patients on effective therapy can join. Women of childbearing potential and men must use contraception during the trial.

Inclusion Criteria

My cancer is not curable with usual treatments and Gemcitabine is a standard option for me.

I have advanced pancreatic or high-grade serous ovarian cancer that cannot be cured with standard treatments.

My ovarian cancer worsened within 6 months after my last platinum-based treatment.

I have pancreatic cancer and received only one chemotherapy treatment for it when it spread.

My brain cancer has not worsened 4 weeks after treatment, and I haven't taken steroids for 4 weeks.

My kidney function, measured by creatinine clearance or GFR, is within the normal range.

I am 18 years old or older.

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

I stopped taking PARP inhibitors due to worsening condition or severe side effects.

I have ovarian cancer and have had only one or no treatments after becoming resistant to platinum-based therapy.

My hepatitis B virus load is undetectable with treatment.

I have had no more than two rounds of chemotherapy.

I had hepatitis C but am cured, or I'm being treated with no detectable virus.

I have a tumor that can be biopsied and another tumor that can be measured.

Exclusion Criteria

I do not have any stomach or intestine problems that affect how I absorb medication.

I do not have untreated brain metastases.

I am not pregnant or breastfeeding.

I can safely undergo tumor biopsies.

I have never been treated with an ATR inhibitor.

I am allergic to medications similar to elimusertib or gemcitabine.

I have not had radiation on more than 25% of my bone marrow.

I cannot swallow pills.

I do not have any severe illnesses that would stop me from following the study's requirements.

Treatment Details

The trial is testing a combination of gemcitabine (a chemotherapy drug) with elimusertib (an ATR inhibitor) to see if it's safe, find the best dose, and observe its effectiveness against advanced cancers like pancreatic and ovarian cancer. The goal is to determine whether this combo can shrink or stabilize tumors.

1Treatment groups

Experimental Treatment

Group I: Treatment (gemcitabine, elimusertib)Experimental Treatment5 Interventions

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and elimusertib QD or PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial and collection of blood samples during screening and on days 1, 2, and 9-10 of cycle 1. Patients in the dose-expansion portion of the trial also undergo biopsies during screening and on day 9 of cycle 1.