eligibility_summary
Eligibility: confirmed prostate adenocarcinoma, life expectancy >6 mo, castrate testosterone (≤50 ng/dL), progression after ≥1 novel hormonal agent, prior taxane (or refused/ineligible/no access), ≥1 metastatic lesion on recent imaging, PSA ≥1 ng/mL, tumor tissue for IHC (waiver possible), adequate labs, QTc ≤470 ms and no major arrhythmias. Excludes unresolved ≥Grade 2 toxicities, other active malignancies, and ILD/pneumonitis or significant lung disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
- Drug/intervention: ABBV-969, an investigational intravenous immunotherapy given as monotherapy. First‑in‑human Phase 1 with dose escalation and randomized dose expansion to determine RP2D. The specific modality/target and mechanism of action are not disclosed in the registry. - Cells/pathways targeted: Adult metastatic castration‑resistant prostate cancer (mCRPC) tumor cells after progression on novel hormonal agents and typically a taxane. Baseline tumor tissue is required for immunohistochemistry, indicating a biomarker‑driven approach, but the antigen/pathway is unspecified. Overall, the study evaluates an immune‑based therapy intended to act against prostate cancer cells, the exact immune pathway or tumor antigen targeted is not provided.