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 whose primary purpose is to identify the recommended dose for expansion RDE of single agent ELVN-001 in chronic phase or accelerated phase CML with and 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 RDE safety profile, PK and preliminary evidence of anti-CML activity will be used to inform future development 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 tolerable or benefit from available TKIs.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

CML that has failed or the patient is intolerant to available therapies known to be active for treatment of their CML.
ECOG performance status of 0 to 2.
Adequate hematologic, hepatic and renal function.

Exclusion Criteria:

Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
QTc >470 ms.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT05304377

Recruitment Status:

Recruiting

Sponsor:

Enliven Therapeutics

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There are 23 Locations for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Randi Ackerman
Contact
[email protected]
Michael Mauro, Dr
Principal Investigator
Oregon Health & Science University-Knight Cardiovascular Institute
Portland Oregon, 97239, United States More Info
Michael Heinrich
Contact
[email protected]
Michael Heinrich, Dr
Principal Investigator
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Carol Bivins
Contact
[email protected]
Koji Sasaki, Dr
Principal Investigator
Royal Adelaide Hospital
Adelaide , SA 50, Australia More Info
Naranie Shanmuganathan
Contact
[email protected]
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux , 33076, France More Info
Marie-Pierre Fort
Contact
[email protected]
Gabriel Etienne, Dr
Principal Investigator
Centre Hospitalier de Versailles (CHV)
Le Chesnay , 78157, France More Info
Celine Constant
Contact
[email protected]
Christelle Fandom Tchomgouo
Contact
[email protected]
Philippe Rousselot, Prof
Principal Investigator
CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
Lille , 59000, France More Info
Alexandre Nung
Contact
[email protected]
Valerie Coiteux, Dr
Principal Investigator
Centre Hospitalier Lyon Sud
Pierre Benite Cedex , 69495, France More Info
Mohamed El-Hamri
Contact
[email protected]
Marie Balsat, Dr
Principal Investigator
Uniklinik RWTH Aachen Medizinische Klinik III
Aachen , 52074, Germany More Info
Christian Hasenbank
Contact
[email protected]
Martina Crysandt, Dr Med
Principal Investigator
Charite Campus Virchow
Berlin , 13353, Germany More Info
Thekla Schwarzer
Contact
[email protected]
Philipp Le Coutre, Dr
Principal Investigator
Klinikum der Goethe Universitat
Frankfurt , 60596, Germany More Info
Fabian Lang
Contact
[email protected]
Fabian Lang, Dr Med
Principal Investigator
Universitaetsklinikum Jena
Jena , 07747, Germany More Info
Marina Liebing
Contact
[email protected]
Katrin Meinhardt
Contact
[email protected]
Andreas Hochhaus, Prof Dr
Principal Investigator
Medizinische Universitatsklinik Mannheim der Universitat Heidelberg
Mannheim , 68167, Germany More Info
Susanne Saussele
Contact
[email protected]
Susanne Saussele, Prof Dr
Principal Investigator
Chonbuk National University Hospital
Jeonju Jeollabuk-do, 54907, Korea, Republic of More Info
Jae-Yong Kwak, Prof
Contact
[email protected]
Jae-Yong Kwak, Prof
Principal Investigator
Keimyung University Dongsan Hospital
Daegu , 42601, Korea, Republic of More Info
Hana Kang
Contact
[email protected]
Young Rok Do, Prof Dr
Principal Investigator
Uijeongbu Eulji Medical Center
Gyeonggi-do , 11749, Korea, Republic of More Info
Sahee Park
Contact
[email protected]
Dong-Wook Kim, Dr
Principal Investigator
Chonnam National University Hwasun Hospital
Hwasun , 58128, Korea, Republic of More Info
S-E Kim
Contact
[email protected]
Hyeoung-Joon Kim, Dr
Principal Investigator
Samsung Medical Center
Seoul , 06351, Korea, Republic of More Info
Chul Won Jung
Contact
[email protected]
Chul Won Jung, Dr
Principal Investigator
Hospital Del Mar
Barcelona , 08003, Spain More Info
Francesc Garcia Pallarols
Contact
93 248 3225
[email protected]
Patricia Velez Tenza, Dr
Principal Investigator
Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario de Salud (SCS)
Las Palmas De Gran Canaria , 35010, Spain More Info
Maria Teresa Gomez-Casares
Contact
[email protected]
Maria Teresa Gomez-Casares, Dr
Principal Investigator
Hospital Universitario La Paz
Madrid , 28046, Spain More Info
Raquel Gil Ortega
Contact
[email protected]
Maria Raquel de Paz Arias, Dr
Principal Investigator
Hospital Virgen de la Salud
Toledo , 45007, Spain More Info
Nuria Garcia Ormena
Contact
[email protected]
Luis Felipe Casado Montero, Dr
Principal Investigator
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia , 46026, Spain More Info
Silvia Garcia Palomares
Contact
[email protected]
Elvira Mora Castera, Dr
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT05304377

Recruitment Status:

Recruiting

Sponsor:


Enliven Therapeutics

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