eligibility_summary
HER2+ or low-HER2 solid tumors (incl. HER2 mut). HR+ BC: prior CDK4/6. Part 2: BC and GC/GEJ (HER2+ or low) or any solid tumor post SOC. Labs: Plt ≥75k, Hb ≥9, ANC ≥1000, CrCl >45, AST/ALT ≤3× ULN (≤5× liver mets), bili ≤1.5× (≤3× Gilbert/liver), albumin >2.5, INR/PTT ≤1.5× (≤3× if anticoag). No G-CSF ≤2w. Washout: surgery 4w, RT 3w (2w palliative). ECOG 0–1. Exclude ILD/pulmonary, ≥Gr2 ocular disease, unstable CNS mets, active 2nd cancer, major CV/liver disease, serious infection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05872295 tests IKS014, a HER2-targeting antibody-drug conjugate (ADC). Drug type: human monoclonal antibody linked to monomethyl auristatin F (MMAF), an antimitotic microtubule inhibitor. Mechanism: IKS014 binds HER2 (ERBB2) on tumor cells, is internalized, and releases MMAF to disrupt tubulin polymerization, causing cell-cycle arrest and apoptosis. Targets: HER2-expressing cancer cells and HER2 signaling axis, includes HER2-positive and HER2-low breast, gastric, and gastroesophageal junction tumors, and other solid tumors with any HER2 expression or activating HER2 mutations. Phase 1 dose-escalation/expansion, IV Day 1 of 21-day cycles, assessing safety, RP2D, PK/PD, immunogenicity, and preliminary antitumor activity.