OncoMatch/Clinical Trials/NCT05304377
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Is NCT05304377 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ELVN-001 for chronic myeloid leukemia.
Treatment: ELVN-001 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: BCR fusion
BCR-ABL1 positive CML in chronic phase
Required: ABL1 fusion
BCR-ABL1 positive CML in chronic phase
Allowed: ABL1 T315I
with or without T315I mutation
Disease stage
Required: Stage CHRONIC PHASE
BCR-ABL1 positive CML in chronic phase
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: second-generation tyrosine kinase inhibitor
failed or is intolerant to at least one prior second-generation tyrosine kinase inhibitor (TKI)
Must have received: tyrosine kinase inhibitor (asciminib)
failed or is intolerant to at least one prior...asciminib
Lab requirements
Blood counts
Kidney function
Liver function
Adequate hematologic, hepatic and renal function. QTc >470 ms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center · New York, New York
- Montefiore Medical Center · The Bronx, New York
- Oregon Health & Science University-Knight Cardiovascular Institute · Portland, Oregon
- The University of Texas MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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