eligibility_summary
Eligibility: men 18–75, biopsy‑confirmed prostate cancer with ≥1 metastasis, 68Ga‑NY108 PET/CT+, progressive metastases per PCWG3, prior NAAD (enzalutamide/abiraterone) and paclitaxel, ECOG 0–2. Exclude recent major surgery/trauma, serious infection/disease, immune dysfunction, autoimmunity, recent immunosuppressives/vaccines, arrhythmia, NYHA HF, uncontrolled HTN, agent allergy, syphilis/HBV/HCV/HIV, poor contraception, mental illness, unable for SPECT/CT, or otherwise unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: 177Lu-labeled NY108, an anti-PSMA monoclonal antibody radiopharmaceutical (radioimmunoconjugate). Mechanism of action: NY108 specifically binds prostate-specific membrane antigen (PSMA/FOLH1) on prostate cancer cells, the attached lutetium-177 emits gamma photons for SPECT imaging to assess biodistribution and also delivers low-dose beta radiation with potential targeted cytotoxicity. Drug type: monoclonal antibody-based radiotracer/radioimmunoconjugate. Target cells/pathway: PSMA-expressing prostate cancer cells (metastatic, castration-resistant), pathway involves PSMA (glutamate carboxypeptidase II) cell-surface antigen binding and internalization, enabling tumor-targeted radioligand uptake. Study: single-arm, early phase 1 imaging-focused safety/biodistribution assessment.