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DRUG:

EP0042

i
Other names: EP0042, EP 0042, EP-0042
Associations
Trials
Company:
Ellipses Pharma
Drug class:
FLT3 inhibitor, Aurora kinase A inhibitor, Aurora kinase B inhibitor
Related drugs:
Associations
Trials
5ms
Enrollment change • Combination therapy • Metastases
|
EP0042
11ms
EP0042-101: Study to Evaluate the Safety and Tolerability of EP0042 (clinicaltrials.gov)
P1/2, N=50, Recruiting, Ellipses Pharma | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Sep 2023 --> Oct 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
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FLT3 wild-type
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EP0042
1year
EP0042, a Dual FLT3 and Aurora Kinase Inhibitor: Results from an Ongoing Phase I/IIa Dose-Finding/Dose Optimization Study in Patients with Relapsed/Refractory Acute Myeloid Leukemia (ASH 2023)
12 patients received a prior FLT3 inhibitor including midostaurin, gilteritinib or sorafenib and 8/12 patients received ≥2 prior FLT3 inhibitors. Dose optimisation cohorts are continuing to identify the RP2D. Further cohorts are planned for evaluation of EP0042 in combination with standard of care therapies.
Clinical • P1/2 data
|
FLT3 (Fms-related tyrosine kinase 3)
|
FLT3-ITD mutation • FLT3 mutation • FLT3 wild-type
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sorafenib • Xospata (gilteritinib) • Rydapt (midostaurin) • EP0042
2years
EP0042, a Dual FLT3 and Aurora Kinase Inhibitor: Preliminary Results of an Ongoing Phase I/IIa First in Human Study in Patients with Relapsed/Refractory Acute Myeloid Leukemia (ASH 2022)
EP0042 has resulted in inhibition of tumor growth in FLT3-ITD and FLT3-ITD-TKD human tumor xenograft models and in quizartinib-resistant primary AML samples (Moore A et al...5 pts received a prior FLT3 inhibitor including midostaurin, gilteritinib or sorafenib...The dose escalation is continuing at intermittent and continuous dosing to establish the MTD and optimal RP2D dose for further evaluation. Once a RP2D is confirmed, a single arm dose expansion is planned in FLT3 mutated and wild type R/R AML, and the combination of EP0042 with other agents will be explored.
Clinical • P1/2 data
|
FLT3 (Fms-related tyrosine kinase 3) • AURKB (Aurora Kinase B)
|
FLT3 mutation • FLT3 wild-type
|
sorafenib • Xospata (gilteritinib) • Rydapt (midostaurin) • Vanflyta (quizartinib) • EP0042