Clinical trial · Interventional
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
NCT05304377CI-TRIAL-00107056CMLrecruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ONTOLOGY_EXACT | 0.98 |
| Cml | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ELVN-001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1a Dose Escalation
- description
- ELVN-001 administered in 3+3 dose escalation
- interventionNames
- Drug: ELVN-001
- type
- EXPERIMENTAL
- label
- Phase 1b Dose Expansion (non-T315I)
- description
- ELVN-001 administered at one or more recommended dose(s) for expansion in CML without T315I mutations
- interventionNames
- Drug: ELVN-001
- type
- EXPERIMENTAL
- label
- Phase 1b expansion (T315I)
- description
- ELVN-001 administered at the recommended dose for expansion for CML with T315I mutation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.