Drug intelligence / Profile preview

ELVN-002 + trastuzumab + eribulin (Enliven Therapeutics)

Development stage
Phase 1
Lead developer
Enliven Therapeutics
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Intravenous
01

Overview

ELVN-002 + trastuzumab + eribulin is a combination therapy regimen being evaluated by Enliven Therapeutics for the treatment of HER2-positive solid tumors, including breast, colorectal, and gastric cancers. The regimen consists of three components: ELVN-002, a potent, highly selective, and irreversible small molecule tyrosine kinase inhibitor (TKI) designed to target both wild-type HER2 and various HER2 mutations while sparing EGFR; trastuzumab, a HER2-targeted monoclonal antibody; and eribulin, a microtubule inhibitor chemotherapy. This triplet combination aims to provide comprehensive HER2 blockade through dual targeting (extracellular and intracellular) alongside the cytotoxic effects of eribulin. ELVN-002 is specifically engineered to be CNS-penetrant, addressing a significant need in patients with brain metastases. As of 2024, the combination is in Phase 1 development (NCT05650879). However, Enliven Therapeutics has announced plans to explore strategic alternatives for the ELVN-002 program and does not intend to pursue its development beyond 2025 in order to focus on its leukemia candidates.

Other names
eribulintrastuzumaberibulin mesylateELVN002ELVN-002ELVN 002
02

Targets

ERBB2 (Erb-b2 receptor tyrosine kinase 2)TUBB (Tubulin (alpha and beta subunits))

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