eligibility_summary
Includes: metastatic/advanced solid tumors post‑SoC or SoC‑ineligible, ≥1 measurable lesion with CAIX uptake, CAIX+ in ≥75% lesion volume (SUVmax ≥1.5× liver), ECOG 0–1, adequate organ function, life ≥6 mo. Excludes: prior CAIX/radioligand, recent anti‑cancer therapy or radionuclides, >2 cytotoxic lines or severe cytopenias, strong CYP meds, H2‑blockers/PPIs, therapeutic anticoagulation, high‑burden bone/spine/pelvic disease, hypersensitivity, active infection/severe comorbidity, need anticancer therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1b trial testing: 1) 177Lu‑TLX250 (lutetium‑177–DOTA‑girentuximab), a CAIX‑targeted radioligand/radioimmunotherapy using a chimeric monoclonal antibody to deliver β‑radiation to tumors, 2) Peposertib (M3814), an oral small‑molecule DNA‑PK inhibitor that blocks non‑homologous end joining (NHEJ) DNA repair to radiosensitize tumor cells, plus 89Zr‑TLX250 (zirconium‑89–DFO‑girentuximab) as an immunoPET diagnostic to confirm CAIX expression. Targets: CAIX‑positive tumor cells (notably clear‑cell RCC and other solid tumors) via the CAIX surface antigen (upregulated by hypoxia/HIF‑1) and the DNA damage response pathway—specifically DNA‑PKcs in NHEJ—to enhance radiation‑induced cytotoxicity.