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ATR Kinase Inhibitor

Elimusertib (BAY1895344) for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new combination cancer treatment to see how well it works and what the optimal dose is. The new drug, elimusertib, works by blocking a substance produced by the body that is important for the growth of tumor cells. Pembrolizumab is an immunologic checkpoint blocker that promotes an immune response against the tumor.

Eligible Conditions
  • Advanced Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Dose limiting toxicities (DLTs) at each dose level during dose escalation of BAY1895344
Incidence of Treatment Emergent Adverse Events (TEAEs) including Treatment Emergent Serious Adverse Events (TESAEs)
Recommended phase II dose (RP2D) of BAY1895344
+1 more
Secondary outcome measures
AUC(0-12) of Elimusertib
AUC(0-12)md of Elimusertib
Cmax of Elimusertib
+7 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

13Treatment groups
Experimental Treatment
Group I: Dose expansion cohort 6a of ElimusertibExperimental Treatment2 Interventions
Participants with advanced mCRPC and without DDR deficiency alterations as described above, who have not received prior treatment with immunotherapy. VUS of the DDR gene alterations are eligible. Participants with known MSI-H cannot be included.
Group II: Dose expansion cohort 6 of ElimusertibExperimental Treatment2 Interventions
Participants with advanced Metastatic castration-resistant prostate cancer (mCRPC), known to be DDR deficiency biomarker positive (incl. ATM mutation) and/or positive for ATM loss who have not received prior treatment with immunotherapy. Participants with known MSI-H cannot be included.
Group III: Dose expansion cohort 5a of ElimusertibExperimental Treatment2 Interventions
Participants with advanced pancreatic cancer and without DDR deficiency alterations as described above, who have not received prior treatment with immunotherapy. VUS of the DDR gene alterations are eligible. Participants with known MSI-H cannot be included.
Group IV: Dose expansion cohort 5 of ElimusertibExperimental Treatment2 Interventions
Participants with advanced pancreatic cancer, known to be DDR deficiency biomarker-positive (incl. ATM mutation) and/or positive for ATM loss who have not received prior treatment with immunotherapy. Participants with known MSI-H cannot be included.
Group V: Dose expansion cohort 4a of ElimusertibExperimental Treatment2 Interventions
Participants with advanced NSCLC and without DDR deficiency alterations as described above. VUS of the DDR gene alterations are eligible. Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies.
Group VI: Dose expansion cohort 4 of ElimusertibExperimental Treatment2 Interventions
Participants with advanced Non-small cell lung cancer (NSCLC) known to be DDR deficiency biomarker-positive (incl. ATM mutation) and/or positive for ATM loss. Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies.
Group VII: Dose expansion cohort 3a of ElimusertibExperimental Treatment2 Interventions
Participants with advanced GC/GEJ cancer and without DDR deficiency alterations as described above. Variants of unknown significance (VUS) of the DDR gene alterations are eligible. Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies.
Group VIII: Dose expansion cohort 3 of ElimusertibExperimental Treatment2 Interventions
Participants with advanced Gastric/gastroesophageal junction cancer (GC/GEJ) known to be DDR deficiency biomarker-positive (incl. ATM mutation) and/or positive for ATM loss. Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies.
Group IX: Dose expansion cohort 2b of ElimusertibExperimental Treatment2 Interventions
Participants with advanced CRC, known to be DDR deficiency biomarker -positive (except ATM loss/mutation) who have not received prior treatment with immunotherapy. Participants with known MSI-H cannot be included.
Group X: Dose expansion cohort 2a of ElimusertibExperimental Treatment2 Interventions
Participants with advanced Colorectal cancer (CRC) known to be positive for ATM loss and/or ATM deleterious alterations who have not received prior treatment with immunotherapy. Participants with known MSI-H cannot be included.
Group XI: Dose expansion cohort 1b of ElimusertibExperimental Treatment2 Interventions
Participants with advanced hormone-receptor-positive, HER2-negative BC, known to be DDR deficiency biomarker-positive (except ATM loss/mutation) who have not received prior treatment with immunotherapy. Participants with known MSI-H cannot be included.
Group XII: Dose expansion cohort 1a of ElimusertibExperimental Treatment2 Interventions
Participants with advanced hormone-receptor-positive, Human epidermal growth factor receptor 2 negative breast cancer (HER2-negative BC), known to be positive for Ataxia-telangiectasia mutated (ATM) loss and/or ATM deleterious alterations who have not received prior treatment with immunotherapy. Participants with known microsatellite instability-high (MSI-H) cannot be included
Group XIII: Dose escalation of ElimusertibExperimental Treatment2 Interventions
2 dose levels of Elimusertib are planned
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab (Keytruda®)
2019
Completed Phase 1
~140
Elimusertib (BAY1895344)
2019
Completed Phase 1
~290

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,615 Total Patients Enrolled
BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,721 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining openings available in this trial for participants?

"At present, no individuals can be enrolled in this medical trial. It was initially advertised on September 30th 2019 and last updated November 7th 2022. Should you seek other trials to take part in, there are currently 2502 studies actively accepting participants diagnosed with solid tumors or advanced solid tumors and 961 investigations offering Elimusertib (BAY1895344) as a treatment option."

Answered by AI

How many individuals are involved in the clinical trial at its peak?

"This research venture is not presently recruiting. Initially posted on September 30th 2019 and last updated November 7th 2022, the project is currently dormant. If you're keen to explore alternate studies, there are 2,502 trials enrolling individuals with solid tumors while 961 clinical investigations are looking for participants trialling Elimusertib (BAY1895344)."

Answered by AI

What safety precautions should be taken when administering Elimusertib (BAY1895344) to patients?

"Limited evidence of Elimusertib's (BAY1895344) safety and efficacy leads us to assign a score of 1 on our scale from 1-3."

Answered by AI

Has Elimusertib (BAY1895344) been evaluated in past clinical experiments?

"Originally researched in the year 2010 at City of Hope, elimusertib (BAY1895344) is currently being studied in 961 clinical trials. 251 of these studies have been completed while many others are still going on out of Palo Alto, California."

Answered by AI

What is the geographic scope of this medical research in North America?

"This research study is currently operating across 9 distinct locations. Patients in Palo Alto, New Haven and Baltimore are eligible to apply, as well as those residing near 6 other sites. To reduce travel burden, it's important to select a trial site nearest your residence if you opt-in for participation."

Answered by AI

How has Elimusertib (BAY1895344) been employed therapeutically?

"Elimusertib (BAY1895344) is primarily prescribed to combat malignant neoplasms, however it can also be used to manage unresectable melanoma, microsatellite instability and progression of disease post-chemotherapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug
2019. "Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04095273.
~10 spots leftby Apr 2025
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