Clinical trialPhase 1Active not recruiting

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

Phase 1 Trial of Gemcitabine Combined With the Elimusertib (BAY 1895344) ATR Inhibitor With Expansion Cohorts in Advanced Pancreatic and Ovarian Cancer

NCT04616534 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Ongoing
Phase: Phase 1
Status: Active not recruiting
Study type: Interventional
Start: 1 June 2021
Expected end: 20 May 2027
Enrollment: 14 participants
Sites: 3
Primary outcomes: Number of Patients on Treatment With Related Adverse Events; Maximum Tolerated Dose (MTD); Overall Response Rate (ORR); Duration of Response; Progression Free Survival (PFS)
Sponsor: Nih
Results posted: 2026-07-09
Last update: 31 July 2026

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Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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 elimusertib (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 elimusertib (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 elimusertib 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. 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. After completion of study treatment, patients are followed up for 30 days.

Intervention public domain (ClinicalTrials.gov)

Procedure: Biopsy Procedure. Undergo biopsy (dose expansion cohort only)

Intervention public domain (ClinicalTrials.gov)

Procedure: Biospecimen Collection. Undergo collection of blood samples

Intervention public domain (ClinicalTrials.gov)

Procedure: Diagnostic Imaging Testing. Undergo medical imaging scans

Intervention public domain (ClinicalTrials.gov)

Drug: Elimusertib. Given PO

Intervention public domain (ClinicalTrials.gov)

Drug: Gemcitabine. Given IV

Arm public domain (ClinicalTrials.gov)

Treatment (gemcitabine, elimusertib) (experimental): 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.

Primary outcome public domain (ClinicalTrials.gov)

Number of Patients on Treatment With Related Adverse Events. The toxicity of the combination of gemcitabine plus elimusertib will be assessed with Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0 criteria. The safety and tolerability were evaluated using the number of treatment-related adverse events. Time frame: Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024) (3 years and 4 months). Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days..

Primary outcome public domain (ClinicalTrials.gov)

Maximum Tolerated Dose (MTD). A conventional algorithm (3+3 design) will be used to identify the MTD, escalating on zero of three or one of six dose-limiting toxicities (DLTs), and de-escalating if two DLTs are encountered. The MTD will be the highest dose level at which zero of three or one of six subjects experience a DLT. The MTD was not reached due to toxicity experienced during cycle 1. Time frame: The MTD was evaluated during the dose-escalation phase, occurring from the first patient on treatment (Jun '21) through the last patient's last dose (Sep '24) (3 years and 3 months). MTD was evaluated for a median of 58.5 days, ranging 28 - 285 days..

Primary outcome public domain (ClinicalTrials.gov)

Overall Response Rate (ORR). Radiological response will be assessed with Response Evaluation Criteria in Solid Tumors 1.1 criteria and will be portrayed as the percentage of subjects with a complete response (CR) and partial response (PR). Time frame: ORR was assessed from the time of the first patient on study (June 2021) through the last patient off study (October 2024). ORR was calculated for a median of 103 days, ranging from 30 - 312 days..

Primary outcome public domain (ClinicalTrials.gov)

Duration of Response. Time frame: Duration of response was assessed from the time of the first patient on treatment (June 2021) through the last patient off study (October 2024). Duration of response was calculated for a median of 103 days, ranging from 30 - 312 days..

Primary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS). Time frame: PFS was evaluated from the first patient on study (Jun '21) through the last patient's death or date of progressive disease (Sep '24) (3 years and 3 months). PFS was calculated for a median of 90 days, ranging 25 - 286 days..

Secondary outcome public domain (ClinicalTrials.gov)

Pharmacokinetic (PK) Profile of Elimusertib in Combination With Gemcitabine. Time frame: Day 1 of dose-escalation phase (first patient's day 1, June 2021, to last patient's day 1, December 2023) equaling the total collection time of 2 year and 6 months. PK samples for collected on a single day for each participant..

Secondary outcome public domain (ClinicalTrials.gov)

Gemcitabine Pharmacokinetics. Time frame: Days 1 and 8 of cycle 1 dose-escalation (first patient's day 1, June 2021, to last patient's day 8, December 2023) equaling the total collection time of 2 year and 6 months. Samples were collected on two days for each participant..

Secondary outcome public domain (ClinicalTrials.gov)

Presence or Absence of Homologous Recombination (HR) Repair Proficiency (Dose Expansion). Time frame: Pre-treatment to time of disease progression, assessed up to 1 year in the dose expansion cohort.

Secondary outcome public domain (ClinicalTrials.gov)

Presence or Absence of ATR Activation (Dose Expansion). Time frame: Pre-treatment to time of disease progression, assessed up to 1 year in the dose expansion cohort.

Secondary outcome public domain (ClinicalTrials.gov)

Increase in Deoxyribonucleic Acid (DNA) Damage Level (Dose Expansion). Time frame: Pre-treatment and on-treatment in the dose expansion cohort.

Secondary outcome public domain (ClinicalTrials.gov)

Conversion of Cancer With Stable Replication Forks to One With Unstable Replication Forks (Dose Expansion). Time frame: Pre-treatment to time of disease progression, assessed up to 1 year in the dose expansion cohort.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * 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 …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 14 participants (actual).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Patients on Treatment With Related Adverse Events [Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024) (3 years and 4 months). Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.]. Count Of Participants, Participants. Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10 (n=3): 3; Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=2): 2; Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): 3; Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): 3; Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=3): 3.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Maximum Tolerated Dose (MTD) [The MTD was evaluated during the dose-escalation phase, occurring from the first patient on treatment (Jun '21) through the last patient's last dose (Sep '24) (3 years and 3 months). MTD was evaluated for a median of 58.5 days, ranging 28 - 285 days.]. Number, mg. Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10 (n=3): NA [No safe dose was found and the trial was stopped early for toxicity.]; Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=2): NA [No safe dose was found and the trial was stopped early for toxicity.]; Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): NA [No safe dose was found and the trial was stopped early for toxicity.]; Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): NA [No safe dose was found and the trial was stopped early for toxicity.]; Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=3): NA [No safe dose was found and the trial was stopped early for toxicity.].

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Response Rate (ORR) [ORR was assessed from the time of the first patient on study (June 2021) through the last patient off study (October 2024). ORR was calculated for a median of 103 days, ranging from 30 - 312 days.]. Number, percent of participants. Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10 (n=3): 33.3; Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=2): 0; Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): 0; Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): 0; Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=3): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Duration of Response [Duration of response was assessed from the time of the first patient on treatment (June 2021) through the last patient off study (October 2024). Duration of response was calculated for a median of 103 days, ranging from 30 - 312 days.]. Mean, months (Full Range). Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10 (n=3): 0.78 (0 to 2.33); Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=2): 0 (0 to 0); Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): 0 (0 to 0); Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): 0 (0 to 0); Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=3): 0 (0 to 0).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) [PFS was evaluated from the first patient on study (Jun '21) through the last patient's death or date of progressive disease (Sep '24) (3 years and 3 months). PFS was calculated for a median of 90 days, ranging 25 - 286 days.]. Median, months (95% Confidence Interval). Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10 (n=3): NA (NA to NA) [PFS could not be calculated for each individual cohort due to the small sample size.]; Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=2): NA (NA to NA) [PFS could not be calculated for each individual cohort due to the small sample size.]; Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): NA (NA to NA) [PFS could not be calculated for each individual cohort due to the small sample size.]; Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): NA (NA to NA) [PFS could not be calculated for each individual cohort due to the small sample size.]; Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=3): NA (NA to NA) [PFS could not be calculated for each individual cohort due to the small sample size.]; Total Study Population (n=14): 2.89 (1.08 to NA) [Upper limit not reached.].

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival [OS was calculated for a median of 103 days, ranging from 30 - 312 days.]. Mean, days (Full Range). Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10 (n=3): 102.7 (53 to 173); Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=2): 46.0 (30 to 62); Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): 111.0 (34 to 165); Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10 (n=3): 161.0 (41 to 312); Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10 (n=3): 161.7 (91 to 279).