Brief Summary
A research study looking at a new treatment for patients with advancedat a late stage, far along cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs, to investigate different doses of the experimental study drug, EP0042, in order to determine a dosethe amount of medication taken, which is safe, well-tolerated and likely to be effective in treating AML (acutenew, recent, comes with an urgent or significant sense, is sudden, sharp myeloid leukaemiacancer of blood and/or blood forming tissues).
Intervention / Treatment
- Drug: EP0042
Inclusion Criteria
General
- Male or female patients aged ≥ 18 years of age, at the time of informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment., with histological or cytological confirmation of AML
- Ability to understand and provide written informed consent before any study-specific procedures, sampling, or analyses, including access to archival tumor tissuea group of cells that work together to perform a function
- Ability to swallow and retain oral medication
- Sufficient life expectancy to allow the patient to complete at least 1 cycle (28 days) of the treatment period.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status of 0-2 at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening
- In the opinion of the investigator, all other relevant medical conditions must be well-managed and stable for at least 28 days prior to first administration of study drug
- Patients with pathologically confirmed/documented AML or MDS, as defined by the 2022 European LeukaemiaNet (ELN) recommendations, or CMML, as defined by World Health Organization (WHO) criteria, who have relapsed from or are refractory to previous therapy and have failed all (or are not eligible for/intolerant to) available approved therapies for their disease.
- Patients with relapsed/refractory FLT3 WT AML.
- Previous exposure to venetoclax, hypomethylating agent and/or FLT3 inhibitors (gilteritinib, midostorin, quizartinib, sorafenib) is allowed for relapsed/refractory AML patients.
- Mutation status of patients must be known at trial entry.
- Female patients should either be of non-child-bearing potential or must agree to use highly effective methods of contraception from Screening until 6 months following administration of the last dose of study drug
- Male patients must use double barrier contraception from enrolment through treatment and for 6 months following administration of the last dose of study drug