Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy Treatment (Gemcitabine) for Advanced Pancreatic and Ovarian Cancer, and Advanced Solid Tumors

Running, not enrolling · Phase 1

Conditions studied: Advanced Fallopian Tube Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Ovarian Carcinoma, Advanced Pancreatic Adenocarcinoma, Advanced Primary Peritoneal Carcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8, Stage III Fallopian Tube Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage III Primary Peritoneal Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Primary Peritoneal Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT04616534

Run by

National Cancer Institute (NCI)

People needed

14

Starts

2021-06-01

Expected to finish

2027-05-20

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DOSE ESCALATION COHORT:
• Patients must have histologically confirmed solid tumor malignancy that is not curable with standard approaches. Gemcitabine must be considered a standard therapy for the participant's malignancy
• Patients must have a measurable disease, in at least one lesion, for both the dose escalation and expansion cohorts, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
• Patients must have received one line of treatment for their incurable cancer before enrolling in this trial. Patients with rare malignancies for which there is no accepted standard chemotherapy regimen can enroll without any prior treatments
• Patients must not have received more than two lines of cytotoxic chemotherapy
• Patients can have received prior gemcitabine
• Adjuvant chemotherapy is counted as one line of treatment if patients received it within 6 months of their cancer recurring
• There is no limit for lines of prior targeted therapies or immunotherapy
• Patients who received a prior PARP inhibitor must have had progressive disease, or intolerable toxicity, on the PARP inhibitor prior to enrolling on the study
• DOSE EXPANSION COHORT:
• Participants must have a histologically confirmed advanced pancreatic adenocarcinoma or ovarian cancer (high grade serous ovarian, primary peritoneal or fallopian tube cancer) that is not curable with standard approaches. Patients with both metastatic pancreatic cancer and unresectable pancreatic cancer are eligible
• Ovarian cancer:
• Patients with ovarian cancer must have platinum-resistant disease, defined as progression within 6 months after the last platinum regimen
• Patients with ovarian cancer cannot have received more than one prior regimen in the platinum-resistance setting
• Pancreatic cancer:
• Patients with pancreatic cancer cannot have received more than one line of cytotoxic chemotherapy in the metastatic setting
• Adjuvant chemotherapy is not counted as one line of treatment, if patients received it more than 6 months prior to their cancer recurring
• Patients must have a biopsiable disease and at least one separate measurable lesion
• DOSE ESCALATION AND EXPANSION COHORTS:
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Age >= 18 years
• Because no dosing or adverse event data are currently available on the use of elimusertib (BAY 1895344) in combination with gemcitabine in patients < 18 years of age, children are excluded from this study
• Leukocytes >= 3,000/mcL
• Hemoglobin >= 10 g/dL (no red blood cell transfusion is allowed within 3 weeks before starting the trial)
• Neutrophil count >= 1,500 K/mcL (participants must not have received colony stimulating factors [e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor or recombinant erythropoietin] within 3 weeks before initiation of protocol therapy)

You may not qualify if…

• Patients cannot receive chemotherapy, targeted therapy or immunotherapy within 3 weeks of study entry
• Patients who have had radiotherapy within 4 weeks prior to entering the study
• Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia and lymphopenia
• Participants must not have received investigational therapy administered =< 4 weeks or within a time interval less than at least five half-lives of the investigational agent, whichever is longer, before initiation of protocol therapy
• Participants with known untreated brain metastases are excluded from this clinical trial
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to elimusertib (BAY 1895344) or gemcitabine
• Patients receiving any medications that are substrates of CYP3A4 with a narrow therapeutic window, or strong inhibitors/inducers of CYP3A4 are ineligible, if they cannot be transferred to alternative medication. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
• Patients with uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome or psychiatric illness/social situations that would limit compliance with study requirements are excluded
• Patients with psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because elimusertib (BAY 1895344) as a DNA-damage response inhibitor, and gemcitabine may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with elimusertib (BAY 1895344) breastfeeding should be discontinued if the mother is treated with elimusertib (BAY 1895344) and for 4 months after end of treatment. These potential risks may also apply to other agents used in this study
• Patients who have successfully undergone treatment for another, unrelated clinically relevant cancer, >= 3 years post final treatment, are eligible to participate in this study
• Patients cannot have received radiation to more than 25% of their hematopoietically active bone marrow. Pelvic radiation is considered to affect 25% of the haematopoietically active bone marrow, and only one prior course of pelvic radiation is allowed (Hayman et al., 2011)
• Patients previously treated with an ATR inhibitor are excluded
• Participants who have undergone major surgery =< 4 weeks before initiating protocol therapy must have sufficiently recovered from adverse events caused by the procedure, as judged by the treating investigator
• Subjects with a gastrointestinal disorder or malabsorption that could potentially affect the absorption of the study drug are excluded
• Participants with a history of a clinically relevant second primary malignancy within the past 2 years are excluded. Exceptions include resected basal and squamous cell carcinomas of the skin and completely resected carcinoma in situ of any type
• Patients not able to swallow tablets
• For the Dose Expansion Cohort, patients who cannot safely undergo tumor biopsies are excluded

Where it is running

• National Cancer Institute Developmental Therapeutics Clinic — Bethesda, Maryland, United States
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.