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-001

Indication

Chronic Myeloid Leukemia

Organization

Enliven Therapeutics