A Modular, Multipart, Multi-arm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of EP0042 Alone and in Combination With Anti-cancer Treatments in Patients With Advanced Malignancies

Who is this study for? Adult patients with Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or Myelodysplastic Syndrome
What treatments are being studied? EP0042
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ General

• Male or female patients aged ≥ 18 years of age, at the time of informed consent, 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 tissue

• 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 Oncology Group (ECOG) Performance Status of 0-2 at 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

Locations
Other Locations
Australia
Royal Perth Hospital
RECRUITING
Perth
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Erasmus MC
RECRUITING
Rotterdam
United Kingdom
The Royal Marsden
RECRUITING
London
University College London Hospital
RECRUITING
London
The Christie Hospital
RECRUITING
Manchester
Contact Information
Primary
Clinical Trials Team
Enquiries@ellipses.life
+44 20 3743 0992
Time Frame
Start Date: 2020-11-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 70
Treatments
Experimental: Module 1 EP0042
Establishing the safety of EP0042 as a monotherapy and establishing an appropriate dose to take forward into subsequent modules.
Experimental: Module 2 EP0042
* Part A: To evaluate the safety, tolerability, of EP0042 + a Bcl-2 inhibitor (venetoclax) in patients with R/R FLT3 wildtype (WT) AML.~* 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.
Sponsors
Leads: Ellipses Pharma

This content was sourced from clinicaltrials.gov

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