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- Scemblix (asciminib) / Novartis, ELVN-001 / Enliven Therapeutics
ELVN-001, a highly selective ATP-competitive ABL1 tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia alone or in combination with asciminib (Section 17; Poster Board No: 10) - Mar 25, 2025 - Abstract #AACR2025AACR_7996;
Finally, ENU mutagenesis screens were conducted in a Ba/F3 BCR-ABL1 line with ELVN-001 and asciminib, alone and in combination. Results of these studies and their impact on the clinical utility of this combination will be discussed.
- || ELVN-001 / Enliven Therapeutics
Enrollment change: ELVN-001-101: A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (clinicaltrials.gov) - Mar 26, 2024
P1, N=180, Recruiting, Sponsor: Enliven Therapeutics
Results of these studies and their impact on the clinical utility of this combination will be discussed. N=120 --> 180
- | ELVN-001 / Enliven Therap
New P1 trial: A study to evaluate safety, tolerability and pharmacokinetics of ELVN-001 in Normal Healthy Participants- Part B (EUDRACT) - Feb 8, 2024
P1, N=15, Not yet recruiting, Sponsor: Enliven Therapeutics, Inc.
- | ELVN-001 / Enliven Therap
New P1 trial: A study to evaluate safety, tolerability and pharmacokinetics of ELVN-001 in Normal Healthy Participants- Part A (EUDRACT) - Feb 8, 2024
P1, N=15, Not yet recruiting, Sponsor: Enliven Therapeutics, Inc.
- | ELVN-001 / Enliven Therapeutics
Phase classification: ELVN-001-101: A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (clinicaltrials.gov) - Jan 11, 2024
P1, N=120, Recruiting, Sponsor: Enliven Therapeutics
N=120 --> 180 Phase classification: P1a/1b --> P1
- | ELVN-001 / Enliven Therap
New P1 trial: Study to Assess the Safety, Tolerability and Pharmacokinetics Of ELVN-001 In Normal Healthy Participants (EUDRACT) - Sep 1, 2023
P1, N=80, Recruiting, Sponsor: Enliven Therapeutics, Inc.
- ELVN-001 / Enliven Therap
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 () - Aug 31, 2023 - Abstract #SOHO2023SOHO_542;
P1a/1b
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.
- ELVN-001 / Enliven Therap
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 (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_2258;
P1a/1b
Study sponsor: Enliven Therapeutics. NCT05304377 BCR::ABL, Chronic myeloid leukemia, Tyrosine kinase inhibitor, Phase I
- ELVN-001 / Enliven Therap
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 (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4402;
P1a/1b
Study sponsor: Enliven Therapeutics. NCT05304377 ELVN-001-101 Schema:
- ELVN-001 / Enliven Therap
Elvn-001, a Next Generation ATP-Competitive ABL1 Tyrosine Kinase Inhibitor for the Treatment of Chronic Myeloid Leukemia (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_2169;
Of the six small-molecule ABL1 tyrosine kinase inhibitors (TKIs) that have received FDA-approval for the treatment of BCR-ABL1-driven Chronic Myeloid Leukemia (CML), five (Imatinib, Nilotinib, Dasatinib, Ponatinib, Bosutinib) target the ATP-binding site in the kinase domain...Consistent with previously reported findings for ponatinib, while ELVN-001 showed little to no activity against cells expressing a subset of T315I-inclusive BCR-ABL1 compound mutants, the addition of Asciminib resulted in varying degrees of re-sensitizing these mutants to ELVN-001...These anti-tumor activities also compared favorably to currently approved therapies when evaluated head-to-head in these studies. Together, these findings support ELVN-001 as an extremely selective, novel ATP-competitive inhibitor of ABL1 kinase with superior pharmacokinetic and tolerability properties compared to currently approved TKIs and which retains activity against T315I and other key on-target resistance mutations, warranting its further investigation in patients with TKI-resistant/intolerant CML.
- ||| ELVN-001 / Enliven Therapeutics
Enrollment open: ELVN-001-101: A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (clinicaltrials.gov) - Aug 17, 2022
P1a/1b, N=120, Recruiting, Sponsor: Enliven Therapeutics
Together, these findings support ELVN-001 as an extremely selective, novel ATP-competitive inhibitor of ABL1 kinase with superior pharmacokinetic and tolerability properties compared to currently approved TKIs and which retains activity against T315I and other key on-target resistance mutations, warranting its further investigation in patients with TKI-resistant/intolerant CML. Not yet recruiting --> Recruiting
- | ELVN-001 / Enliven Therapeutics
New P1 trial: ELVN-001-101: A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (clinicaltrials.gov) - Mar 31, 2022
P1a/1b, N=120, Not yet recruiting, Sponsor: Enliven Therapeutics