eligibility_summary
HER2+ by IHC 1–3+ (mut OK), unresectable/metastatic. Cohorts: 1) HNC (oral/salivary/oro-/hypopharynx/larynx, not nasopharynx) after platinum. 2) NSCLC post‑platinum (incl ≤6m periop/CRT relapse), prior anti‑PD(L)1, AGA‑targeted if AGA, ≤2 prior chemo lines. 3) Ovarian platinum‑resistant, ≤4 lines, PARPi if BRCA. 4) Endometrial post‑platinum, ≤3 lines. RECIST measurable, FFPE tissue, ECOG 0–1. Exclude prior MMAE, excipient allergy, recent invasive cancer (<2y)/residual, active untreated CNS/LM.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 basket trial of disitamab vedotin (RC48), an antibody-drug conjugate: a humanized anti-HER2 IgG1 linked via a cleavable vedotin linker to monomethyl auristatin E (MMAE), a microtubule-disrupting cytotoxic. Given IV every 2 weeks as monotherapy in previously treated HER2-expressing head and neck, NSCLC, ovarian, and endometrial cancers. Mechanism: binds HER2 (ERBB2) on tumor cells, internalizes, then releases MMAE to inhibit tubulin polymerization, causing G2/M arrest and apoptosis, Fc may trigger ADCC and payload may cause bystander killing. Targets: HER2+ tumor cells, ERBB2 signaling, microtubules/cell cycle.