Clinical trial
A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
Name
ELVN-001-101
Description
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.
Trial arms
Trial start
2022-05-22
Estimated PCD
2026-12-01
Trial end
2026-12-01
Status
Recruiting
Phase
Early phase I
Treatment
ELVN-001
orally once or twice daily
Arms:
Phase 1a Dose Escalation, Phase 1b Dose Expansion at recommended dose level 1, Phase 1b Dose Expansion at recommended dose level 2, Phase 1b expansion arm in T315I mutated CML
Size
180
Primary endpoint
Phase 1a: Incidence of dose limiting toxicities
28 days
Phase 1a: Incidence of adverse events (AEs)
up to 28 days
Phase 1a: Incidence of clinically significant laboratory abnormalities
up to 28 days
Phase 1a: Incidence of clinically significant ECG abnormalities
up to 28 days
Phase 1b: Incidence of adverse events
up to 3 years
Phase 1b: Incidence of clinically significant laboratory abnormalities
up to 3 years
Phase 1b: Incidence of clinically significant ECG abnormalities
up to 3 years
Eligibility criteria
Inclusion Criteria:
* BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.
* The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML.
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}
Updated at
2024-04-09
1 organization
1 product
1 indication
Product
ELVN-001Indication
Chronic Myeloid LeukemiaOrganization
Enliven Therapeutics