eligibility_summary
Key inclusion: HER2+ solid tumors (IHC3+ or IHC2+/ISH+, CRC also HER2 amp and RAS/BRAF WT), locally advanced/metastatic/unresectable. Prior standard therapy per tumor/part, Part 3/4: no prior HER2 therapy, Part 2: no prior HER2 TKI, CRC in Parts 2/4 eligible for CAPEOX or mFOLFOX6. ECOG 0–1, adequate organs, measurable disease (Parts 3/4). Key exclusions: recent anticancer therapy, active CNS disease or steroids >2 mg dex, uncontrolled seizures, ≥G2 neuropathy (chemo cohorts), malabsorption, unresolved >G1 AEs, prolonged QTc.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1a/1b trial testing ELVN-002 with trastuzumab ± chemotherapy in advanced HER2+ solid tumors (colorectal, breast, gastric, others). ELVN-002: oral small-molecule, HER2-selective tyrosine kinase inhibitor that blocks HER2 phosphorylation and downstream PI3K/AKT and RAS/RAF/MEK/ERK signaling (designed to spare EGFR). Trastuzumab: IV anti-HER2 IgG1 monoclonal antibody that inhibits HER2 signaling/dimerization and induces ADCC against HER2-overexpressing cells. Added by cohort: capecitabine/5-FU (antimetabolites inhibiting thymidylate synthase), leucovorin (potentiates 5-FU), oxaliplatin (DNA crosslinking platinum), paclitaxel (microtubule-stabilizing taxane), eribulin (microtubule depolymerization inhibitor). Targets: HER2-amplified/overexpressed tumor cells, pathways: ERBB2/HER2 signaling and downstream proliferation/survival cascades, cytotoxics target DNA synthesis or microtubules.