A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Chronic Myeloid Leukemia | Cml | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 PositiveThe purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.
null
Conditions de participation
-
Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
Inclusion Criteria:
* BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.
* The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML.
* ECOG performance status of 0 to 2.
* Adequate hematologic, hepatic and renal function.
* Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.
Exclusion Criteria:
* Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
* History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.
* QTc \>470 ms.
Lieu de l'étude
University Health Network (UHN) - Princess Margaret Cancer Centre
University Health Network (UHN) - Princess Margaret Cancer CentreToronto, Ontario
Canada
Contactez l'équipe d'étude
Dong Hwan Dennis Kim, Dr
(416) 946-4501- Étude parrainée par
- Enliven Therapeutics
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05304377