OncoMatch/Clinical Trials/NCT05304377
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Is NCT05304377 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT05304377 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received second-generation tyrosine kinase inhibitor and tyrosine kinase inhibitor.
Does this trial require BCR?
Yes, BCR fusion is a required biomarker for enrollment.
Does this trial require ABL1?
Yes, ABL1 fusion is a required biomarker for enrollment.
What disease stage is eligible?
Stage CHRONIC PHASE is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify