search
Back to results

A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (CML)

Primary Purpose

Chronic Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ELVN-001
Sponsored by
Enliven Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • Oregon Health & Science University-Knight Cardiovascular InstituteRecruiting
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Royal Adelaide HospitalRecruiting
  • Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud OuestRecruiting
  • Centre Hospitalier de Versailles (CHV)Recruiting
  • CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU LilleRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Uniklinik RWTH Aachen Medizinische Klinik IIIRecruiting
  • Charite Campus VirchowRecruiting
  • Klinikum der Goethe UniversitatRecruiting
  • Universitaetsklinikum JenaRecruiting
  • Medizinische Universitatsklinik Mannheim der Universitat HeidelbergRecruiting
  • Chonbuk National University HospitalRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • Uijeongbu Eulji Medical CenterRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Hospital Del MarRecruiting
  • Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario de Salud (SCS)
  • Hospital Universitario La PazRecruiting
  • Hospital Virgen de la SaludRecruiting
  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

phase 1b expansion arm at recommended dose level 1

Phase 1b expansion arm at recommended dose level 2

Phase 1b expansion arm in T315I mutated CML

Phase 1a dose escalation in CML

Arm Description

ELVN-001 administered orally once daily at RDE-1 in CML without T315I mutations

ELVN-001 administered orally once daily at RDE-2 in CML without T315I mutations

ELVN-001 administered orally once daily at RDE-3

ELVN-001 administered orally once daily in 3+3 dose escalation

Outcomes

Primary Outcome Measures

Phase 1a: Incidence of dose limiting toxicities
DLTs will be used to support that the recommended doses for expansion are </= MTD
Phase 1a: Incidence of adverse events (AEs)
Adverse events will be used to support that the recommended doses for expansion are likely to be tolerable
Phase 1a: Incidence of clinically significant laboratory abnormalities
Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Phase 1a: Incidence of clinically significant ECG abnormalities
Clinically significant ECG abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Phase 1b: incidence of adverse events
Adverse events will be used to support that the dose(s) evaluated in expansion is tolerable
Phase 1b: Incidence of clinically significant laboratory abnormalities
Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in expansion is tolerable
Phase 1b: Incidence of clinically significant ECG abnormalities
Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in expansion is tolerable

Secondary Outcome Measures

Phase 1a and 1b: area under the curve
PK parameter based on measurement of drug concentration in blood over time
Phase 1a and 1b: maximum concentration
PK parameter based on measurement of drug concentration in blood
Phase 1a and 1b: time of maximum concentration
PK parameter which is the time at which the highest concentration of drug in the blood is measured
Phase 1a and 1b: minimum concentration
PK parameter based on the measurement of the drug concentration that is at the lowest level once steady state has been achieved.
Phase 1a and 1b: molecular response
measured by quantitative polymerase chain reaction of BCR-ABL transcript levels
Phase 1b: duration of molecular response
time from first molecular response (as measured by quantitative polymerase chain reaction of BCR-ABL transcript levels) to loss of response or discontinuation of study drug
Phase 1b: frequency of complete cytogenetic remission (CCyR)
The proportion of patients who achieve CCyR by serum BCR-ABL1 transcript level who are not in CHR at baseline
Phase 1b: Rate of complete hematologic response (CHR)
The proportion of patients who achieve a CHR who are not in CHR at baseline

Full Information

First Posted
March 15, 2022
Last Updated
April 20, 2023
Sponsor
Enliven Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT05304377
Brief Title
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Acronym
CML
Official Title
A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2022 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enliven Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
phase 1b expansion arm at recommended dose level 1
Arm Type
Experimental
Arm Description
ELVN-001 administered orally once daily at RDE-1 in CML without T315I mutations
Arm Title
Phase 1b expansion arm at recommended dose level 2
Arm Type
Experimental
Arm Description
ELVN-001 administered orally once daily at RDE-2 in CML without T315I mutations
Arm Title
Phase 1b expansion arm in T315I mutated CML
Arm Type
Experimental
Arm Description
ELVN-001 administered orally once daily at RDE-3
Arm Title
Phase 1a dose escalation in CML
Arm Type
Experimental
Arm Description
ELVN-001 administered orally once daily in 3+3 dose escalation
Intervention Type
Drug
Intervention Name(s)
ELVN-001
Intervention Description
orally once daily
Primary Outcome Measure Information:
Title
Phase 1a: Incidence of dose limiting toxicities
Description
DLTs will be used to support that the recommended doses for expansion are </= MTD
Time Frame
28 days
Title
Phase 1a: Incidence of adverse events (AEs)
Description
Adverse events will be used to support that the recommended doses for expansion are likely to be tolerable
Time Frame
up to 28 days
Title
Phase 1a: Incidence of clinically significant laboratory abnormalities
Description
Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Time Frame
up to 28 days
Title
Phase 1a: Incidence of clinically significant ECG abnormalities
Description
Clinically significant ECG abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Time Frame
up to 28 days
Title
Phase 1b: incidence of adverse events
Description
Adverse events will be used to support that the dose(s) evaluated in expansion is tolerable
Time Frame
up to 3 years
Title
Phase 1b: Incidence of clinically significant laboratory abnormalities
Description
Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in expansion is tolerable
Time Frame
up to 3 years
Title
Phase 1b: Incidence of clinically significant ECG abnormalities
Description
Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in expansion is tolerable
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Phase 1a and 1b: area under the curve
Description
PK parameter based on measurement of drug concentration in blood over time
Time Frame
6 months
Title
Phase 1a and 1b: maximum concentration
Description
PK parameter based on measurement of drug concentration in blood
Time Frame
6 months
Title
Phase 1a and 1b: time of maximum concentration
Description
PK parameter which is the time at which the highest concentration of drug in the blood is measured
Time Frame
6 months
Title
Phase 1a and 1b: minimum concentration
Description
PK parameter based on the measurement of the drug concentration that is at the lowest level once steady state has been achieved.
Time Frame
6 months
Title
Phase 1a and 1b: molecular response
Description
measured by quantitative polymerase chain reaction of BCR-ABL transcript levels
Time Frame
up to 3 years
Title
Phase 1b: duration of molecular response
Description
time from first molecular response (as measured by quantitative polymerase chain reaction of BCR-ABL transcript levels) to loss of response or discontinuation of study drug
Time Frame
up to 3 years
Title
Phase 1b: frequency of complete cytogenetic remission (CCyR)
Description
The proportion of patients who achieve CCyR by serum BCR-ABL1 transcript level who are not in CHR at baseline
Time Frame
up to 3 years
Title
Phase 1b: Rate of complete hematologic response (CHR)
Description
The proportion of patients who achieve a CHR who are not in CHR at baseline
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Collins, MD
Phone
707 799-3272
Email
helen.collins@enliventherapeutics.com
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randi Ackerman
Email
ackermar@mskcc.org
First Name & Middle Initial & Last Name & Degree
Michael Mauro, Dr
Facility Name
Oregon Health & Science University-Knight Cardiovascular Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Heinrich
Email
heinrich@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Michael Heinrich, Dr
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Bivins
Email
cbibins@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Koji Sasaki, Dr
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
SA 5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Hughes
Email
tim.hughes@sahmri.com
Facility Name
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre Fort
Email
m.fort@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Gabriel Etienne, Dr
Facility Name
Centre Hospitalier de Versailles (CHV)
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celine Constant
Email
cconstant@ch-versailles.fr
First Name & Middle Initial & Last Name & Degree
Christelle Fandom Tchomgouo
Email
cfandomtchomgouo@ch-versailles.fr
First Name & Middle Initial & Last Name & Degree
Philippe Rousselot, Prof
Facility Name
CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Nung
Email
Alexandre.NUNG@chu-lille.fr
First Name & Middle Initial & Last Name & Degree
Valerie Coiteux, Dr
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed El-Hamri
Email
mohamed.el-hamri@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Marie Balsat, Dr
Facility Name
Uniklinik RWTH Aachen Medizinische Klinik III
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Hasenbank
Email
chasenbank@ukaachen.de
First Name & Middle Initial & Last Name & Degree
Martina Crysandt, Dr Med
Facility Name
Charite Campus Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thekla Schwarzer
Email
thekla.schwarzer@charite.de
First Name & Middle Initial & Last Name & Degree
Philipp Le Coutre, Dr
Facility Name
Klinikum der Goethe Universitat
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabian Lang
Email
fabian.lang@kgu.de
First Name & Middle Initial & Last Name & Degree
Fabian Lang, Dr Med
Facility Name
Universitaetsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Liebing
Email
Marina.Liebing@med.uni-jena.de
First Name & Middle Initial & Last Name & Degree
Katrin Meinhardt
Email
Katrin.meinhardt@med.uni-jena.de
First Name & Middle Initial & Last Name & Degree
Andreas Hochhaus, Prof Dr
Facility Name
Medizinische Universitatsklinik Mannheim der Universitat Heidelberg
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Saussele
Email
susanne.saussele@medma.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Susanne Saussele, Prof Dr
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Yong Kwak, Prof
Email
jykwak@chonbuk.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae-Yong Kwak, Prof
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hana Kang
Email
smilekhn23@gmail.com
First Name & Middle Initial & Last Name & Degree
Young Rok Do, Prof Dr
Facility Name
Uijeongbu Eulji Medical Center
City
Gyeonggi-do
ZIP/Postal Code
11749
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sahee Park
Email
saheepark@eulji.ac.kr
First Name & Middle Initial & Last Name & Degree
Dong-Wook Kim, Dr
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S-E Kim
Email
rlatmdp@hanmail.net
First Name & Middle Initial & Last Name & Degree
Hyeoung-Joon Kim, Dr
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chul Won Jung
Email
chulwon1.jung@samsung.com
First Name & Middle Initial & Last Name & Degree
Chul Won Jung, Dr
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesc Garcia Pallarols
Phone
93 248 3225
Email
fgarcia1@imim.es
First Name & Middle Initial & Last Name & Degree
Patricia Velez Tenza, Dr
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario de Salud (SCS)
City
Las Palmas De Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Teresa Gomez-Casares
Email
mgomcasf@gobiernodecanarias.org
First Name & Middle Initial & Last Name & Degree
Maria Teresa Gomez-Casares, Dr
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Gil Ortega
Email
raquelhematologia@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Raquel de Paz Arias, Dr
Facility Name
Hospital Virgen de la Salud
City
Toledo
ZIP/Postal Code
45007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Garcia Ormena
Email
ceganur@gmail.com
First Name & Middle Initial & Last Name & Degree
Luis Felipe Casado Montero, Dr
Facility Name
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Garcia Palomares
Email
garcia_silpal@gva.es
First Name & Middle Initial & Last Name & Degree
Elvira Mora Castera, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

We'll reach out to this number within 24 hrs