Spots Global Cancer Trial Database for A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
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Trial Identification
Brief Title: A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Official Title: A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
Study ID: NCT05304377
Conditions
Interventions
Study Description
Brief 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.
Detailed 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Oregon Health & Science University-Knight Cardiovascular Institute, Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Royal Adelaide Hospital, Adelaide, , Australia
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, , France
Centre Hospitalier de Versailles (CHV), Le Chesnay, , France
CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille, Lille, , France
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren, Limoges, , France
Centre Leon Berard, Lyon, , France
Centre Hospitalier Lyon Sud, Pierre Benite Cedex, , France
Uniklinik RWTH Aachen Medizinische Klinik III, Aachen, , Germany
Charite Campus Virchow, Berlin, , Germany
Klinikum der Goethe Universitat, Frankfurt, , Germany
Universitaetsklinikum Jena, Jena, , Germany
Medizinische Universitatsklinik Mannheim der Universitat Heidelberg, Mannheim, , Germany
Chonbuk National University Hospital, Jeonju, Jeollabuk-do, Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
Uijeongbu Eulji Medical Center, Gyeonggi-do, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Hospital Del Mar, Barcelona, , Spain
Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario e Salud (SCS), Las Palmas De Gran Canaria, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Complejo Hospitalario de Toledo - Hospital Virgen de la Salud, Toledo, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur), Valencia, , Spain
Contact Details
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