Myeloproliferative Neoplasms Clinical Trial
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Summary
The 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.
Full Description
This first-in-human trial with ELVN-001 is a dose escalation study with the primary purpose to identify the recommended dose(s) for expansion (RDEs) of single agent ELVN-001 in chronic phase CML with or without T315I mutations. The safety, tolerability and pharmacokinetic profile of ELVN-001 will be assessed together with an evaluation of changes in BCR-ABL1 transcript. An understanding of the safety profile, PK and preliminary evidence of anti-CML activity will be used to inform future development of ELVN-001 in adults with CML. By virtue of its predicted pharmacological profile ELVN-001 has the potential to be tolerable and achieve a deep molecular response in patients with CML with or without T315I mutations who do not tolerate or benefit from available TKIs.
Eligibility Criteria
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.
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There are 25 Locations for this study
Portland Oregon, 97239, United States More Info
Bordeaux , 33076, France More Info
Le Chesnay , 78157, France
Lille , 59000, France More Info
Limoges , 87000, France More Info
Mannheim , 68167, Germany More Info
Jeonju Jeollabuk-do, 54907, Korea, Republic of
Daegu , 42601, Korea, Republic of
Hwasun , 58128, Korea, Republic of
Seoul , 06351, Korea, Republic of
Las Palmas De Gran Canaria , 35010, Spain
Valencia , 46026, Spain More Info
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