Recruiting
Phase 1

ELVN-001

Sponsor:

Enliven Therapeutics

Code:

NCT05304377

Conditions

Chronic Myeloid Leukemia

Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive

Cml

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ELVN-001

Study Details

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.

Conditions

Chronic Myeloid Leukemia

Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive

Cml

Study ID

NCT05304377

Start date

May 22, 2022

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.
  • US: The patient has failed or is intolerant to at least one prior second-generation tyrosine kinase inhibitor (TKI) or asciminib. Rest of World: The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML (country-specific criteria may vary).
  • 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.

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

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a Dose Escalation

ELVN-001 administered in 3+3 dose escalation

experimental: Phase 1b Dose Expansion (non-T315I)

ELVN-001 administered at one or more recommended dose(s) for expansion in CML without T315I mutations

experimental: Phase 1b expansion (T315I)

ELVN-001 administered at the recommended dose for expansion for CML with T315I mutation

Interventions

ELVN-001

orally once or twice daily

Primary outcome measure

  • Phase 1a: Incidence of dose limiting toxicities [ Time Frame: 28 days ]
  • Phase 1a: Incidence of adverse events (AEs) [ Time Frame: up to 28 days ]
  • Phase 1a: Incidence of clinically significant laboratory abnormalities [ Time Frame: up to 28 days ]
  • Phase 1a: Incidence of clinically significant ECG abnormalities [ Time Frame: up to 28 days ]
  • Phase 1b: Incidence of adverse events [ Time Frame: up to 3 years ]
  • Phase 1b: Incidence of clinically significant laboratory abnormalities [ Time Frame: up to 3 years ]
  • Phase 1b: Incidence of clinically significant ECG abnormalities [ Time Frame: up to 3 years ]

Central Contacts and Locations

Central contacts

Study Contact

707-799-3272ELVN-001-101@enliventherapeutics.com

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Michael Mauro, MD

+1 347 798 9213

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

David Levitz MD

718-920-4321

Oregon Health & Science University-Knight Cardiovascular Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Michael Heinrich, MD

(503) 418-1964

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Fadi Haddad, MD

877-632-6789

University Health Network (UHN) - Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Dong Hwan Dennis Kim, Dr

+1 416 946 4501

More Information

Sponsor

Enliven Therapeutics

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • CML
  • Tyrosine kinase inhibitor
  • T315I
  • T315I mutant
  • BCR-ABL
  • ENABLE
  • active site inhibitor of BCR-ABL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Enliven Therapeutics on 2026-04-01.