Elimusertib for Solid Cancers

Not currently recruiting at 31 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4 drugs

Disqualifiers: Pregnancy, Active CNS metastasis, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the safest and most effective dose of elimusertib for treating solid tumors that have returned or stopped responding to standard treatments. Elimusertib blocks enzymes that aid tumor cell growth. Individuals with solid tumors, including rare ones like Ewing Sarcoma or those with specific genetic alterations, may qualify if their cancer has recurred or is unresponsive to other treatments. Participants must be able to swallow tablets and have tumors that can be measured or evaluated. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this potentially groundbreaking therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot be on other investigational drugs, anti-cancer agents, or certain medications like cyclosporine and tacrolimus. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that elimusertib is likely to be safe for humans?

Research shows that elimusertib is being tested for its safety in treating solid tumors. In earlier studies, patients with various solid tumors received elimusertib, and results indicated it is generally well-tolerated. Some patients experienced side effects, mostly mild to moderate.

Elimusertib blocks certain enzymes that help cancer cells grow, potentially stopping cancer growth. Although some side effects, like nausea or tiredness, were reported, these are similar to those seen with other cancer treatments.

The current trials are still in the early stages of studying elimusertib's safety, so more information is needed to fully understand its safety. However, existing data suggests that elimusertib is reasonably safe for patients with solid tumors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Elimusertib is unique because it targets cancer cells with a novel mechanism of action, specifically inhibiting a protein involved in DNA damage response, which is not the focus of most standard treatments. Standard therapies for solid cancers typically include chemotherapy or radiation, which can affect both cancerous and healthy cells. Elimusertib selectively targets tumor cells, potentially reducing side effects and improving effectiveness. Researchers are excited about this treatment because it offers a promising new approach for patients who may not respond well to existing therapies.

What evidence suggests that elimusertib might be an effective treatment for solid tumors?

Research has shown that elimusertib, the investigational treatment in this trial, holds promise for treating various solid tumors. Studies have found that elimusertib, a drug that inhibits certain enzymes necessary for cancer cell growth, exhibits strong anti-tumor effects. It is particularly effective in cases with specific DNA repair issues, common in many cancers. Early tests demonstrated that elimusertib can sometimes outperform standard chemotherapy. This suggests that elimusertib could be a powerful treatment option for solid tumors that are challenging to treat with current therapies. ^{3 5 6 7 8}

Who Is on the Research Team?

Michael V Ortiz

Principal Investigator

Pediatric Early Phase Clinical Trial Network

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a solid tumor or lymphoma diagnosis, not originating in the brain.

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.

Exclusion Criteria

Patients currently receiving another investigational drug

Patients currently receiving other anti-cancer agents

Patients who may not be able to comply with the safety monitoring requirements of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elimusertib orally twice daily 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.

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Every 3 months for 12 months, every 6 months for 24 months, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Elimusertib

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (elimusertib) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12402799/

Efficacy of ATR Kinase Inhibitor Elimusertib Monotherapy ... We examined the efficacy of elimusertib monotherapy in a panel of 21 PDX models with a range of DDR pathway alterations. These PDXs represented multiple tumor ...

2. biorxiv.org biorxiv.org/content/10.1101/2022.11.10.515290.full

Elimusertib outperforms standard of care chemotherapy in ... Elimusertib has strong preclinical anti-tumor activity in pediatric solid tumor models, which may translate to clinically meaningful responses in patients.

3. aacrjournals.org aacrjournals.org/cancerres/article/82/12_Supplement/CT006/701956/Abstract-CT006-Phase-Ib-expansion-trial-of-the

Abstract CT006: Phase Ib expansion trial of the safety and ... ... cancer (CRPC); HER2− breast cancer (BC); gynecologic (GYN, mainly ovarian and endometrial); and advanced cancers with ATM IHC loss. Pts ...

4. ecancer.org ecancer.org/en/video/10298-safety-and-efficacy-of-the-oral-atr-inhibitor-elimusertib-in-advanced-solid-tumours-with-dna-damage-response-defects

Safety and efficacy of the oral ATR inhibitor elimusertib in ... Element Certif is a potent and highly selective atr inhibitor and has demonstrated promising anti-tumor activity against a range of solid tumors.

5. researchgate.net researchgate.net/publication/365429082_Elimusertib_outperforms_standard_of_care_chemotherapy_in_preclinical_patient-derived_pediatric_solid_tumor_models

Elimusertib outperforms standard of care chemotherapy in ... Elimusertib has Antitumor Activity in Preclinical Patient-Derived Pediatric Solid Tumor Models. December 2023 · Molecular Cancer Therapeutics.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41104717/

The ATR inhibitor Elimusertib in Combination with Cisplatin ... The ATR inhibitor Elimusertib in Combination with Cisplatin in Patients with Advanced Solid Tumors: a California Cancer Consortium Phase I Trial ...

7. aacrjournals.org aacrjournals.org/cancerdiscovery/article/15/10/2019/765953/Phase-Ib-Basket-Expansion-Trial-and-Alternative

Phase Ib Basket Expansion Trial and Alternative-Schedule ... ... cancers with prospectively selected DDR defects were treated with elimusertib ... solid tumours (DDRiver Solid Tumours 301): Part A1 results . Ann Oncol. 2022.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05071209

Elimusertib for the Treatment of Relapsed or Refractory ... Elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Detailed Description. PRIMARY OBJECTIVES: I. To estimate ...