An AI-designed gallium-68 PET tracer targeting PARP-1 completed a first-in-human evaluation in breast and ovarian cancer patients. The project used an AI-assisted design pipeline to generate [68Ga]Ga-DOTA-FZPF and then move into early clinical imaging to assess safety and detect PARP-1 expression. PARP-1 remains a central target for both therapeutic development and companion diagnostics in DNA damage repair–driven cancers. A tracer capable of mapping target engagement and distribution could improve patient stratification for PARP inhibitors and combination regimens. The next readouts expected from this program include imaging quality metrics, dosimetry, and whether tracer signal tracks with response or resistance biomarkers in larger cohorts.