Enliven Therapeutics, Inc. ((ELVN)) announced an update on their ongoing clinical study.
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Enliven Therapeutics, Inc. is conducting a Phase 1a/1b study titled ‘A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia.’ The study aims to evaluate the safety, tolerability, and determine the recommended dose of ELVN-001 in patients with chronic myeloid leukemia (CML), particularly those who are relapsed, refractory, or intolerant to tyrosine kinase inhibitors (TKIs), including those with T315I mutations.
The intervention being tested is ELVN-001, an oral drug intended to provide a new treatment option for CML patients who do not respond well to existing TKIs. The study seeks to establish its safety profile and effectiveness in achieving a deep molecular response.
The study is designed as an interventional trial with a non-randomized, sequential intervention model. It is unmasked and primarily focused on treatment. The study involves dose escalation and expansion phases to identify the optimal dosing strategy.
The study began on May 22, 2022, with a primary completion date yet to be announced. The latest update was submitted on June 30, 2025, indicating ongoing progress in the study.
This clinical update could potentially influence Enliven Therapeutics’ stock performance positively if ELVN-001 shows promising results, especially given the unmet need in the CML treatment landscape. Investors may view this as a significant development, potentially impacting market sentiment and positioning Enliven competitively within the oncology sector.
The study is currently recruiting, and further details can be accessed on the ClinicalTrials portal.