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.

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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.

View Eligibility Criteria

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.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT05304377

Recruitment Status:

Recruiting

Sponsor:

Enliven Therapeutics

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There are 28 Locations for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Michael Mauro, MD
Contact
347-798-9213
Oregon Health & Science University-Knight Cardiovascular Institute
Portland Oregon, 97239, United States More Info
Michael Heinrich, MD
Contact
503-418-1964
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Koji Sasaki, MD
Contact
877-632-6789
Royal Adelaide Hospital
Adelaide , SA 50, Australia More Info
Naranie Shanmuganathan, Dr
Contact
+61 8 7074 0000
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada More Info
Dong Hwan Dennis Kim, Dr
Contact
416-946-4501
CHU Amiens Picardie Site Sud
Amiens , 80054, France More Info
Amandine Charbonnier, Dr
Contact
+33 3 22 45 59 14
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux , 33076, France More Info
Gabriel Etienne, Dr
Contact
+33 5 56 33 33 33
Centre Hospitalier de Versailles (CHV)
Le Chesnay , 78157, France
CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
Lille , 59000, France More Info
Valerie Coiteux, Dr
Contact
+33 3 20 44 59 62
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
Limoges , 87000, France More Info
Pascal Turlure, Dr
Contact
+33 5 55 05 55 55
Centre Leon Berard
Lyon , 69008, France More Info
Franck Nicolini, Dr
Contact
+04 78 78 28 28
Centre Hospitalier Lyon Sud
Pierre Benite Cedex , 69495, France More Info
Marie Balsat, Dr
Contact
+33 825 08 25 69
Uniklinik RWTH Aachen Medizinische Klinik III
Aachen , 52074, Germany More Info
Martina Crysandt, Dr Med
Contact
+49 241 8080862
Charite Campus Virchow
Berlin , 13353, Germany More Info
Philipp Le Coutre, Dr
Contact
+49 30 45050
Klinikum der Goethe Universitat
Frankfurt , 60596, Germany More Info
Fabian Lang, Dr Med
Contact
+49 821 4861274
Universitaetsklinikum Jena
Jena , 07747, Germany More Info
Andreas Hochhaus, Prof Dr
Contact
+49 3641 9300
Medizinische Universitatsklinik Mannheim der Universitat Heidelberg
Mannheim , 68167, Germany More Info
Susanne Saussele, Prof Dr
Contact
+49 621 3830
Universitaetsmedizin Rostock
Rostock , 18057, Germany More Info
Christian Junghanss, Dr
Contact
0381-494 7421
Chonbuk National University Hospital
Jeonju Jeollabuk-do, 54907, Korea, Republic of
Keimyung University Dongsan Hospital
Daegu , 42601, Korea, Republic of
Uijeongbu Eulji Medical Center
Gyeonggi-do , 11749, Korea, Republic of More Info
Dong-Wook Kim, Dr
Contact
+82 31-1899-0001
Chonnam National University Hwasun Hospital
Hwasun , 58128, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Hospital Del Mar
Barcelona , 08003, Spain More Info
Patricia Velez Tenza, Dr
Contact
+34 932 48 30 00
Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario e Salud (SCS)
Las Palmas De Gran Canaria , 35010, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain More Info
Maria Raquel de Paz Arias, Dr
Contact
+34 917 27 70 00
Complejo Hospitalario de Toledo - Hospital Virgen de la Salud
Toledo , 45007, Spain More Info
Luis Felipe Casado Montero, Dr
Contact
+34 925 39 68 90
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia , 46026, Spain More Info
Elvira Mora Castera, Dr
Contact
+34 961 24 40 00

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT05304377

Recruitment Status:

Recruiting

Sponsor:


Enliven Therapeutics

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