eligibility_summary
Eligibility: ≥18 with adv/metastatic clear‑cell RCC, measurable disease, ECOG 0–1, adequate organ fxn, negative pregnancy/contraception, oral meds ok, tumor tissue, controlled brain mets allowed. Exclusions: prior systemic mRCC therapy, CNS disease (leptomeningeal or unstable/steroid‑dependent brain mets), recent RT or major surgery, uncontrolled HTN or CV events, active infection, CYP3A4 modulators, malabsorption/high‑risk GI disease, hepatic/renal failure or transplant, other active malignancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions and mechanisms: • 177Lu‑girentuximab: CAIX‑targeted monoclonal antibody conjugated to beta‑emitter lutetium‑177 (radioimmunotherapy). Binds CAIX on ccRCC cells and delivers localized radiation to kill tumor cells. • Nivolumab: anti‑PD‑1 monoclonal antibody (immune checkpoint inhibitor) that blocks PD‑1 to restore T‑cell activity against tumor. • Cabozantinib: oral small‑molecule multi‑tyrosine kinase inhibitor, primarily inhibits MET, VEGFR2 (KDR), and AXL (also RET, KIT, FLT3, TIE2), reducing angiogenesis, tumor growth, and invasiveness. • [18F]F‑AraG: PET radiotracer (deoxyguanosine analog) used to image activated T cells, not therapeutic. Cells/pathways targeted: • CAIX‑expressing ccRCC tumor cells. • PD‑1 pathway on T cells to enhance antitumor immunity. • VEGF/MET/AXL signaling in tumor cells and vasculature/microenvironment. • Activated T‑cell trafficking/activation (imaging with [18F]F‑AraG).