EXS74539 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and optimal dose of a new treatment, EXS74539, for certain solid tumors. It targets individuals whose cancer has progressed or returned after other treatments. Those with cancers such as small cell lung cancer, prostate cancer, or triple-negative breast cancer, who have not improved with previous treatments, might be suitable candidates for this study. The trial will help researchers determine the treatment's effectiveness and its impact on the body. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have brain metastases, you must be off corticosteroids and anticonvulsants for at least one month before starting the study treatment.
Is there any evidence suggesting that EXS74539 is likely to be safe for humans?
Research has shown that EXS74539, a treatment under study for certain solid tumors, remains in the early testing stages. As a result, detailed safety information for humans is limited. However, lab and animal tests have shown promise. For instance, one study found that EXS74539 affected cancer cells from acute myeloid leukemia (AML) without significantly impacting blood platelet counts, a positive safety indicator.
The FDA approved EXS74539 for testing, indicating it met the basic safety standards required to begin human trials. In this early phase, researchers focus primarily on assessing the drug's safety and determining the appropriate dosage. Participants should understand that the trial's main goals are to evaluate the treatment's safety and tolerability.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for solid tumors, which often involve chemotherapy or radiation, EXS74539 is unique because it targets tumor cells with a novel mechanism of action. Researchers are excited about EXS74539 because it potentially offers a more precise approach to attacking cancer cells, minimizing damage to healthy cells. This targeted action could lead to fewer side effects and improved outcomes for patients compared to existing therapies.
What evidence suggests that EXS74539 might be an effective treatment for solid tumors?
Research has shown that EXS74539 yields promising early results in fighting certain types of cancer. Initial tests, conducted in labs or with animals, demonstrated that EXS74539 can effectively target and kill cancer cells, particularly in acute myeloid leukemia (AML), a type of blood cancer. The treatment blocks LSD1, an enzyme that aids cancer cell growth. This method might also benefit those with solid tumors. Although these findings are preliminary, they provide a reason to study EXS74539 further in individuals with solid tumors.12367
Are You a Good Fit for This Trial?
This trial is for adults with certain advanced solid tumors (like lung, prostate, kidney, ovarian, breast, liver, stomach cancers) whose cancer has worsened or returned after at least one standard treatment. Participants must be in good physical condition and have measurable disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose-Escalation Treatment
Participants receive escalating doses of EXS74539 to determine safety, tolerability, and maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EXS74539
Trial Overview
The study is testing different doses of a new drug called EXS74539 to find the safest dose that people can tolerate. It focuses on safety and how well patients handle the medication.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
EXS74539
Find a Clinic Near You
Who Is Running the Clinical Trial?
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Lead Sponsor
Citations
Determining anti-cancer efficacy of a reversible LSD1 ...
Conclusions: Our preclinical data demonstrated ex vivo efficacy of '539 against AML blast cells and supported the combinatorial potential of '539 with first ...
EXS74539 for Solid Tumors
The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in ...
EXS74539 / Recursion Pharma
Recursion Announces Two Key Investigational Oncology Drugs Advancing to Clinical Trials, Targeting High Unmet Needs...Small-Cell Lung Cancer, ...
2289P Determining anti-cancer efficacy of a reversible ...
2289P Determining anti-cancer efficacy of a reversible LSD1 inhibitor, EXS74539, in primary AML tissues with limited thrombocytopenic effects.
Dose Determining Study of EXS74539 (REC-4539) in ...
The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select ...
REC-4539 - Drug Targets, Indications, Patents
... Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors. 100 Clinical Results associated with ...
7.
targetedonc.com
targetedonc.com/view/fda-clears-investigational-new-drug-application-for-rec-4539-in-sclcFDA Clears Investigational New Drug Application for REC ...
The FDA has cleared the IND application for REC-4539, a novel LSD1 inhibitor, initiating a phase 1/2 clinical trial in SCLC and other solid tumor indications.
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