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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

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
Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive 0 0
Cml 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
Homburg
Country [16] 0 0
Germany
State/province [16] 0 0
Jena
Country [17] 0 0
Germany
State/province [17] 0 0
Mannheim
Country [18] 0 0
Germany
State/province [18] 0 0
Rostock
Country [19] 0 0
Israel
State/province [19] 0 0
Jerusalem
Country [20] 0 0
Israel
State/province [20] 0 0
Nahariya
Country [21] 0 0
Israel
State/province [21] 0 0
Petah Tikva
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Jeollabuk-do
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Daegu
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Gyeonggi-do
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Hwasun
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Spain
State/province [28] 0 0
Las Palmas De Gran Canaria
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Toledo
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05304377