A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

Part of paid clinical trials in New York, New York.

Sponsor
Enliven Therapeutics
Study ID
NCT05304377
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ELVN-001 — DRUG
    orally once or twice daily

Study Details

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.

Key Dates

Start date
May 22, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Phase 1a: Incidence of dose limiting toxicities [ Time Frame: 28 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Michael Mauro, MD
+1 347 798 9213
Montefiore Medical CenterThe BronxNew York10461
David Levitz MD
718-920-4321
Oregon Health & Science University-Knight Cardiovascular InstitutePortlandOregon97239
Michael Heinrich, MD
(503) 418-1964
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Fadi Haddad, MD
877-632-6789

Find similar trials in New York, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Memorial Sloan Kettering Cancer Center· New York, NYMontefiore Medical Center· The Bronx, NYOregon Health & Science University-Knight Cardiovascular Institute· Portland, ORThe University of Texas MD Anderson Cancer Center· Houston, TX

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