Enliven Therapeutics’ Promising Phase 1a/1b Study on ELVN-002 in HER2+ Cancers

Enliven Therapeutics, Inc. ((ELVN)) announced an update on their ongoing clinical study.

Enliven Therapeutics, Inc. is conducting a Phase 1a/1b clinical study titled A Phase 1a/1b Study of ELVN-002 Combined With Trastuzumab in Advanced Stage HER2+ Solid Tumors, and ELVN-002 Combined With Trastuzumab and Chemotherapy in Advanced Stage HER2+ Colorectal Cancer and Breast Cancer. The study aims to determine the safety, tolerability, and recommended dose of ELVN-002, a new drug, in combination with trastuzumab, and in some cases, chemotherapy, for patients with advanced-stage HER2-positive tumors. This study is significant as it explores potential new treatment combinations for difficult-to-treat cancers.

The interventions being tested include the oral drug ELVN-002 and the intravenous drug trastuzumab. In certain study parts, chemotherapy drugs such as capecitabine, oxaliplatin, 5-fluorouracil, leucovorin, eribulin, and paclitaxel are also included. These combinations aim to enhance treatment efficacy for HER2-positive cancers.

This interventional study is non-randomized and follows a sequential intervention model. It is designed to escalate doses in Phase 1a and expand doses in Phase 1b, focusing on treatment as the primary purpose. There is no masking involved in this study.

The study started on May 30, 2024, with its primary completion and estimated completion dates yet to be announced. The latest update was submitted on July 16, 2025. These dates are crucial for tracking the progress and expected outcomes of the study.

The update on this study could influence Enliven Therapeutics’ stock performance and investor sentiment positively, especially if the results show promising efficacy and safety. This could position Enliven favorably against competitors in the oncology sector, potentially leading to increased market interest and investment.

The study is ongoing, and further details are available on the ClinicalTrials portal.