eligibility_summary
Adults 18–74 with advanced solid tumors lacking standard options, HER2 expressed/positive/amplified or mutated (IHC/ISH/NGS). Stage Ia: evaluable disease, Stage Ib: measurable HER2+ breast, urothelial, gastric/GEJ, ovarian, endometrial, NSCLC (HER2mut), or CRC (HER2+, RAS/BRAF WT). ECOG 0–1, survival ≥12 wks, adequate labs, contraception. Exclude active/untreated CNS mets, recent therapy/surgery, ILD, HIV/HBV/HCV, active infection/effusions, major CV/QT/HTN, prior transplant, severe allergy, unresolved ≥G2 AEs, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: KM501, a recombinant humanized anti‑HER2 double‑antibody (bispecific) antibody–drug conjugate (ADC) carrying the cytotoxic payload MMAE (monomethyl auristatin E). Mechanism of action: The bispecific antibody binds HER2 on tumor cells (expressed/amplified/mutated), is internalized, and releases MMAE intracellularly to inhibit tubulin polymerization, causing mitotic arrest and apoptosis, potential Fc-mediated effector functions may contribute. Drug type: Targeted biologic ADC with a microtubule‑disrupting payload. Targets (cells/pathways): HER2/ERBB2‑positive tumor cells across solid tumors (e.g., breast, gastric/GEJ, urothelial, ovarian, endometrial, HER2‑mutant NSCLC, HER2‑amplified CRC), pathways include the HER2 signaling axis and the microtubule cytoskeleton. Phase: First‑in‑human, single‑arm, dose‑escalation/expansion.