^
    2d
    Study to Assess the Safety, Tolerability and Pharmacokinetics Of ELVN-001 In Normal Healthy Participants (ACTRN12623000760673)
    P1, N=80, Completed, Enliven Therapeutics, Inc. | Recruiting --> Completed
    Trial completion
    |
    ELVN-001
    9ms
    ELVN-001-101: A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (clinicaltrials.gov)
    P1, N=180, Recruiting, Enliven Therapeutics | N=120 --> 180
    Enrollment change
    |
    ELVN-001
    12ms
    ELVN-001-101: A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (clinicaltrials.gov)
    P1, N=120, Recruiting, Enliven Therapeutics | Phase classification: P1a/1b --> P1
    Phase classification
    |
    ELVN-001
    over1year
    Study to Assess the Safety, Tolerability and Pharmacokinetics Of ELVN-001 In Normal Healthy Participants (ACTRN12623000760673)
    P1, N=80, Recruiting, Enliven Therapeutics, Inc.
    New P1 trial
    |
    ELVN-001
    over1year
    First‑in‑Human Phase I Study of ELVN‑001, an Oral, Selective BCR::ABL1 Tyrosine Kinase Inhibitor, in Patients With Chronic Myeloid Leukemia Who Failed Prior Tyrosine Kinase Inhibitors (SOHO 2023)
    Secondary endpoints are PK and molecular response, and for phase Ib, duration of molecular response, BCR::ABL1 transcript levels, and complete hematologic response. Ongoing analyses will determine the RDE of ELVN-001 and evaluate its safety and PK profile while assessing preliminary efficacy.
    Clinical • P1 data
    |
    ABL1 (ABL proto-oncogene 1)
    |
    ABL1 T315I
    |
    ELVN-001
    over1year
    TRIALS IN PROGRESS: FIRST-IN-HUMAN STUDY OF ELVN-001, A SELECTIVE BCR::ABL1 TYROSINE KINASE INHIBITOR, IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA WHO FAILED PREVIOUS TYROSINE KINASE INHIBITOR THERAPIES (EHA 2023)
    Ba/F3 cells expressing a range of the most prevalent on-target BCR::ABL1 resistance mutants indicated that with the exception of certain P-loop mutations and F317L, ELVN-001 maintained potency, including for the myristoyl pocket mutations A344P and P465S and was active against the M244V mutation, an ATP pocket mutation known to confer resistance to asciminib. This FIH study will evaluate dosing, safety, tolerability, PK profile, and preliminary efficacy of ELVN-001 in CP-CML with and without T315I mutation. Study sponsor: Enliven Therapeutics. NCT05304377 BCR::ABL, Chronic myeloid leukemia, Tyrosine kinase inhibitor, Phase I
    Clinical • P1 data
    |
    ABL1 (ABL proto-oncogene 1) • KDR (Kinase insert domain receptor) • LYN (LYN Proto-Oncogene Src Family Tyrosine Kinase)
    |
    ABL1 T315I • ABL1 F317L
    |
    Scemblix (asciminib) • ELVN-001
    2years
    First-in-Human Study of Elvn-001, a Highly Selective BCR::ABL1 Tyrosine Kinase Inhibitor, in Patients with Chronic Myeloid Leukemia Who Failed Previous Tyrosine Kinase Inhibitor Therapies (ASH 2022)
    This FIH study will evaluate dosing, safety, tolerability, PK profile and preliminary efficacy of ELVN-001 in CP-CML with and without T315I mutation. Study sponsor: Enliven Therapeutics. NCT05304377 ELVN-001-101 Schema:
    Clinical • P1 data
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • KDR (Kinase insert domain receptor) • LYN (LYN Proto-Oncogene Src Family Tyrosine Kinase) • CA9 (Carbonic anhydrase 9)
    |
    ABL1 T315I
    |
    ELVN-001
    over2years
    A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (clinicaltrials.gov)
    P1a/1b, N=120, Recruiting, Enliven Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    ELVN-001
    over2years
    A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (clinicaltrials.gov)
    P1a/1b, N=120, Not yet recruiting, Enliven Therapeutics
    New P1 trial
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    ELVN-001