Evaluating a new treatment for advanced blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and tolerability of an experimental drug, EP0042, in patients with advanced blood cancers such as Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), and Myelodysplastic Syndromes (MDS). It aims to determine the appropriate dosing that is safe and effective for these patients. Participants will receive the drug over a treatment cycle of 28 days, and their responses will be monitored closely to assess the drug's impact.

Why it matters

Who can join: the full rules

General

1. Male or female patients aged ≥ 18 years of age, at the time of informed consent, with histological or cytological confirmation of AML
2. Ability to understand and provide written informed consent before any study-specific procedures, sampling, or analyses, including access to archival tumor tissue
3. Ability to swallow and retain oral medication
4. Sufficient life expectancy to allow the patient to complete at least 1 cycle (28 days) of the treatment period.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at screening
6. 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
7. 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.
8. Patients with relapsed/refractory FLT3 WT AML.
9. Previous exposure to venetoclax, hypomethylating agent and/or FLT3 inhibitors (gilteritinib, midostaurin, quizartinib, sorafenib) is allowed for relapsed/refractory AML patients.
10. Mutation status of patients must be known at trial entry.
11. 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
12. Male patients must use double barrier contraception from enrolment through treatment and for 6 months following administration of the last dose of study drug

5.2 Core Exclusion Criteria

Patients with any of the following will not be included in the study:

Disease Under Study and Prior Anticancer Treatment

1. Suspected brain and/or leptomeningeal metastases that are symptomatic or untreated or that require current therapy
2. Acute promyelocytic leukemia (FAB:M3)
3. Systemic anti-cancer therapy for the disease under study within 2 weeks of the first dose of study treatment. If the previous anti-cancer therapy has a very long half-life and may interact with EP0042, e.g. a strong CYP3A4 inhibitor, the washout period may need to be increased for safety reasons but will be no longer than 3 weeks (Concomitant hydroxyurea is acceptable and will be permitted throughout the screening period and during first 6 cycles of study treatment)
4. Ongoing toxic manifestations of previous treatments that have not reduced to at least 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.
5. Transplantation (allogeneic or autologous) within last 90 days, or on active immunosuppressive therapy for graft versus host disease in last 2 weeks

   Laboratory Parameters
6. Patient with any out-of-range laboratory values defined as shown below.

   • Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 50 mL/ min
7. Inadequate liver function as demonstrated by

   * total serum bilirubin ≥ 1.5 times the upper limits of normal range (ULN) or
   * ALT ≥3 times the ULN or
   * AST ≥3 times the ULN or
   * AST or ALT ≥5 times the ULN in the presence of liver involvement by leukemia

Where it's running

• Royal Perth Hospital
  Perth, Western Australia, Australia Recruiting
• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Erasmus MC
  Rotterdam, Netherlands Recruiting
• The Royal Marsden
  London, UK, United Kingdom Recruiting
• University College London Hospital
  London, United Kingdom Recruiting
• The Christie Hospital
  Manchester, United Kingdom Recruiting

Study contacts

• Principal investigator: David Taussig — The Royal Marsden, UK
• Study coordinator: Clinical Trials Team
• Email: Enquiries@ellipses.life
• Phone: +44 20 3743 0992

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.