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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05304377




Registration number
NCT05304377
Ethics application status
Date submitted
15/03/2022
Date registered
31/03/2022
Date last updated
13/06/2024

Titles & IDs
Public title
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Scientific title
A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
Secondary ID [1] 0 0
ELVN-001-101
Universal Trial Number (UTN)
Trial acronym
CML
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ELVN-001

Experimental: Phase 1a Dose Escalation - ELVN-001 administered in 3+3 dose escalation

Experimental: Phase 1b Dose Expansion at recommended dose level 1 - ELVN-001 administered at the recommended dose in CML without T315I mutations

Experimental: Phase 1b Dose Expansion at recommended dose level 2 - ELVN-001 administered at a different recommended dose in CML without T315I mutations

Experimental: Phase 1b expansion arm in T315I mutated CML - ELVN-001 administered at the recommended dose for CML with T315I mutation


Treatment: Drugs: ELVN-001
orally once or twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: Incidence of dose limiting toxicities
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Phase 1a: Incidence of adverse events (AEs)
Timepoint [2] 0 0
up to 28 days
Primary outcome [3] 0 0
Phase 1a: Incidence of clinically significant laboratory abnormalities
Timepoint [3] 0 0
up to 28 days
Primary outcome [4] 0 0
Phase 1a: Incidence of clinically significant ECG abnormalities
Timepoint [4] 0 0
up to 28 days
Primary outcome [5] 0 0
Phase 1b: Incidence of adverse events
Timepoint [5] 0 0
up to 3 years
Primary outcome [6] 0 0
Phase 1b: Incidence of clinically significant laboratory abnormalities
Timepoint [6] 0 0
up to 3 years
Primary outcome [7] 0 0
Phase 1b: Incidence of clinically significant ECG abnormalities
Timepoint [7] 0 0
up to 3 years
Secondary outcome [1] 0 0
Phase 1a and 1b: area under the curve
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Phase 1a and 1b: maximum concentration
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Phase 1a and 1b: time of maximum concentration
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Phase 1a and 1b: minimum concentration
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Phase 1a and 1b: Molecular response (MR)
Timepoint [5] 0 0
up to 3 years
Secondary outcome [6] 0 0
Phase 1b: Duration of Molecular Response
Timepoint [6] 0 0
up to 3 years
Secondary outcome [7] 0 0
Phase 1b: Complete Hematologic Response (CHR)
Timepoint [7] 0 0
up to 3 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Oregon
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
France
State/province [5] 0 0
Amiens
Country [6] 0 0
France
State/province [6] 0 0
Bordeaux
Country [7] 0 0
France
State/province [7] 0 0
Le Chesnay
Country [8] 0 0
France
State/province [8] 0 0
Lille
Country [9] 0 0
France
State/province [9] 0 0
Limoges
Country [10] 0 0
France
State/province [10] 0 0
Lyon
Country [11] 0 0
France
State/province [11] 0 0
Pierre Benite Cedex
Country [12] 0 0
Germany
State/province [12] 0 0
Aachen
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Frankfurt
Country [15] 0 0
Germany
State/province [15] 0 0
Jena
Country [16] 0 0
Germany
State/province [16] 0 0
Mannheim
Country [17] 0 0
Germany
State/province [17] 0 0
Rostock
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Jeollabuk-do
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Daegu
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Gyeonggi-do
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Hwasun
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Las Palmas De Gran Canaria
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid
Country [26] 0 0
Spain
State/province [26] 0 0
Toledo
Country [27] 0 0
Spain
State/province [27] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Enliven Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05304377
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
707-799-3272
Fax 0 0
Email 0 0
ELVN-001-101@enliventherapeutics.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05304377