eligibility_summary
Adults ≥18 with CD44v6+ metastatic/locally advanced, unresectable ATC/PDTC/RAI‑R DTC, HNSCC, NSCLC, vulvar or cervical SCC, progressed after standard therapies, measurable disease (RECIST 1.1), ECOG 0–1, ≥3‑mo life expectancy, adequate organ/cardiac function, and contraception. Exclude: untreated symptomatic brain mets, recent other cancers, therapy <4 wks, >Grade 1 toxicities, pregnancy/lactation, uncontrolled disease, severe skin disease, HIV/HBV/HCV, or active TB.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: [177Lu]Lu-AKIR001, a radiopharmaceutical radioimmunotherapy (lutetium‑177–labeled monoclonal antibody) targeting CD44v6. Mechanism: AKIR001 binds the CD44v6 isoform on tumor cell surfaces, the 177Lu β-emitter delivers localized ionizing radiation, causing DNA damage/strand breaks and cell death, with potential cross‑fire killing of adjacent CD44v6+ tumor cells. Target cells/pathways: CD44v6‑expressing epithelial tumors (e.g., anaplastic/poorly differentiated thyroid cancer, head & neck SCC, cervical and vulvar SCC, NSCLC). Biological pathway: CD44v6 (a hyaluronan receptor variant) implicated in cell adhesion/migration and co‑signaling with growth factor pathways (e.g., MET/EGFR→MAPK/PI3K).