What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly those involving enzyme inhibitors like Elimusertib, often result in side effects such as nausea, diarrhea, and hand-foot syndrome (palmar-plantar erythrodysesthesia). Other frequent adverse effects include fatigue, neutropenia (low white blood cell count), and neuropathy (nerve damage). In some cases, severe toxicities such as febrile neutropenia, severe diarrhea, and significant fatigue can occur. These side effects can vary in intensity and duration, impacting the patient's quality of life and requiring careful management.

What prior FDA approvals exist?

Several enzyme inhibitors have received FDA approval for the treatment of solid tumors. For instance, pembrolizumab, a PD-1 inhibitor, has been approved for various cancers including metastatic melanoma and non-small cell lung cancer. Similarly, cemiplimab, another PD-1 inhibitor, has shown efficacy in advanced non-small cell lung cancer. These treatments work by blocking specific enzymes involved in tumor growth and immune evasion, similar to the mechanism being studied for elimusertib in treating relapsed or refractory solid tumors.

What other types of research exist?

Promising novel alternatives to Elimusertib for solid tumors include: 1) Pembrolizumab, which has shown efficacy in metastatic sarcomatoid renal cell carcinoma, 2) Atezolizumab plus Bevacizumab, which has demonstrated potential in advanced renal cell carcinoma, and 3) Fulvestrant plus Everolimus, which has been effective in hormone-receptor positive, HER2-negative metastatic breast cancer.

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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

Must not have

Patients currently receiving drugs that are strong inducers or inhibitors of CYP3A4

Patients receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests elimusertib, a pill that blocks enzymes needed for cancer cell growth, in children and young adults with difficult-to-treat cancers. The drug aims to stop cancer cells from repairing and growing.

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.

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.

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

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My cancer has come back or didn't respond to treatment, and was confirmed by a biopsy.

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

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I am between 12 months and 18 years old.

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I am between 12 and 21 years old and eligible for the phase 2 study.

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My bilirubin levels are within the normal range for my age.

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My kidney function, measured by creatinine clearance or GFR, is normal or above 70 mL/min.

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My blood counts meet the required levels and I don't have cancer in my bone marrow.

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My nerve-related side effects from previous treatments are mild.

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I am between 12 months and 30 years old, eligible for phase 2 of the study.

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My body surface area is at least 0.74 square meters.

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I can swallow pills without any issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking medication that strongly affects liver enzyme CYP3A4.

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I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.

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My cancer has spread to my brain.

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I do not have any infections that are currently uncontrolled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of cycle 1 dose limiting toxicities for BAY 1895344 (elimusertib)

Response of BAY 1895344 (elimusertib)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 15Eligibility criteria met

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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