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Protein Kinase Inhibitor

Elimusertib for Solid Cancers

Phase 1 & 2
Waitlist Available
Led By Michael V Ortiz
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with recurrent or refractory solid tumors. Patients must have had histologic verification of malignancy at original diagnosis or relapse
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective in treating patients with solid tumors that have returned or stopped responding to treatment.

Who is the study for?
This trial is for young patients (up to 30 years old) with solid tumors or lymphoma that have returned or are treatment-resistant. They must be able to swallow pills, not currently on other cancer treatments or strong CYP3A4 drugs, and can't have active brain metastases or uncontrolled infections.Check my eligibility
What is being tested?
The trial is testing Elimusertib's safety and optimal dosage in treating relapsed/refractory solid tumors. It aims to see if it can halt tumor growth by blocking enzymes needed for cell proliferation.See study design
What are the potential side effects?
Potential side effects of Elimusertib may include issues related to the nervous system, digestive disturbances, changes in blood counts, liver function alterations, and possibly fatigue due to its mechanism of inhibiting cellular enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My cancer has come back or didn't respond to treatment, and was confirmed by a biopsy.
I can take care of myself but may not be able to do heavy physical work.
I am between 12 months and 18 years old.
I am between 12 and 21 years old and eligible for the phase 2 study.
My bilirubin levels are within the normal range for my age.
My kidney function, measured by creatinine clearance or GFR, is normal or above 70 mL/min.
My blood counts meet the required levels and I don't have cancer in my bone marrow.
My nerve-related side effects from previous treatments are mild.
I am between 12 months and 30 years old, eligible for phase 2 of the study.
My body surface area is at least 0.74 square meters.
I can swallow pills without any issues.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 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 cycle 1 dose limiting toxicities for BAY 1895344 (elimusertib)
Response of BAY 1895344 (elimusertib)
Secondary outcome measures
Area under the drug concentration time curve of BAY 1895344 (elimusertib)
Change in pH2AX of BAY 1895344 (elimusertib)
Change in pKAP1 of BAY 1895344 (elimusertib)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (elimusertib)Experimental Treatment1 Intervention
Patients receive elimusertib PO BID on days 1-3, 8-10, 15-17, and 22-24 of each cycle. Treatment repeats every 28 days for 26 cycles in the absence of disease progression or unacceptable toxicity.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Elimusertib works by inhibiting specific enzymes necessary for tumor cell growth, effectively halting the proliferation of cancer cells. This mechanism is crucial for solid tumor patients as it targets the fundamental processes that allow cancer to thrive and spread. Other common treatments for solid tumors include chemotherapy, which kills rapidly dividing cells, and targeted therapies that focus on specific molecular abnormalities in cancer cells. Understanding these mechanisms helps in selecting the most effective treatment strategy, potentially improving outcomes and minimizing side effects.
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Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,734 Previous Clinical Trials
40,967,581 Total Patients Enrolled
Michael V OrtizPrincipal InvestigatorPediatric Early Phase Clinical Trial Network

Media Library

Elimusertib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05071209 — Phase 1 & 2
Solid Tumors Research Study Groups: Treatment (elimusertib)
Solid Tumors Clinical Trial 2023: Elimusertib Highlights & Side Effects. Trial Name: NCT05071209 — Phase 1 & 2
Elimusertib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05071209 — Phase 1 & 2
~0 spots leftby Jun 2024