A research study looking at a new treatment for patients with advanced cancer, to investigate different doses of the experimental study drug, EP0042, in order to determine a dose, which is safe, well tolerated and likely to be effective in treating AML (acute myeloid leukaemia).
EU CTIS ID: 2024-514588-24-00
What this study is testing
Core Primary Objectives: 1. To investigate the safety and tolerability of EP0042 given alone or in combination with anti-cancer treatments. Module 1 Primary Objectives: 1. To investigate the safety and tolerability of EP0042 given as a monotherapy in patients with relapsed or refractory (R/R) AML(AML, MDS or CMML). Module 2 Primary Objectives: 1. Part A: To evaluate the safety, tolerability, of EP0042 + a Bcl-2 inhibitor (venetoclax) in patients with R/R FLT3 wildtype (WT) AML. 2. Part B: To evaluate the safety, tolerability, of EP0042 in combination with a Bcl-2 inhibitor (venetoclax) + a hypomethylating agent(azacitidine) in patients with R/R FLT3 WT or newly diagnosed AML.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Core Inclusion Criteria: 1. Male or female patients aged ≥ 18 years of age, at the time of informed consent, with histological or cytologicalconfirmation of leukemia. 2. Ability to understand and provide written informed consent before any study-specific procedures, sampling, oranalyses, including access to archival tumor tissue. 3. Ability to swallow and retain oral medication.
You likely can't join if
- Core Exclusion Criteria: 1. Suspected brain and/or leptomeningeal metastases that are symptomatic or untreated or that require current therapy. 2. Ongoing toxic manifestations of previous treatments that have not reduced to at least Common Terminology Criteria for Adverse Events (CTCAE) Grade 1. Exceptions to this are alopecia or certain Grade 2 treatment related toxicities, which in the opinion of the Investigator should not exclude the patient. 3. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/min. 4. Receiving an investigational anti-cancer treatment concurrently or within 14 days or five half-lives of either the parent drug or any active metabolite prior to the start of treatment with EP0042. Patients with AML may receive hydroxyurea throughout the screening period and during the first 2 cycles of study treatment in the first module(FIH study). 5. Current refractory nausea and vomiting, malabsorption syndrome, disease significantly affecting gastrointestinal(GI) function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery such as gastric bypass. 6. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection. 7. Patients with active human immunodeficiency virus infection (HIV) infection (testing is not required). Patients living with HIV will be eligible if they have CD4+ T-cell count ≥ 350 cells/μL, no history of AIDS-defining opportunistic infections in the past 12 months, and can be managed on a regimen consistent with this protocol's permitted concomitant medications. 8. Malignant disease other than that being treated in this study, with the following exceptions: a. Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment. b. Completely resected basal cell and squamous cell skin cancers. c. Any malignancy considered to be indolent and that has never required therapy. d. Completely resected carcinoma in situ of any type. 9. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results. 10. Any major surgical procedure (in the investigator's judgement) within 2 weeks of the first dose of study drug. 11. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.