Elimusertib for Solid Cancers
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.12345Why 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.35678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
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 ...
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-theAbstract 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 ...
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_modelsElimusertib outperforms standard of care chemotherapy in ...
Elimusertib has Antitumor Activity in Preclinical Patient-Derived Pediatric Solid Tumor Models. December 2023 · Molecular Cancer Therapeutics.
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-AlternativePhase 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.
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 ...
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