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
Overview
- Phase
- Phase 1
- Intervention
- EP0042
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- Ellipses Pharma
- Enrollment
- 70
- Locations
- 6
- Primary Endpoint
- Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period.
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Module 1 EP0042
Establishing the safety of EP0042 as a monotherapy and establishing an appropriate dose to take forward into subsequent modules.
Intervention: EP0042
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.
Intervention: EP0042
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.
Intervention: Venetoclax
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.
Intervention: Azacitidine (AZA)
Outcomes
Primary Outcomes
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period.
Time Frame: First cycle of treatment (28 Days)
Incidence of dose-limiting toxicities (DLT)