eligibility_summary
Eligible: men with prostate adenocarcinoma—mCRPC (most arms, some require PSA ≥2 ng/mL) or mHSPC (Part 2H, PSA >0.2 ng/mL after 180–365 days of ARPI without progression, no prior cytotoxic chemo). Measurable/evaluable disease, ECOG 0–1, adequate organ function. Prior ARPI required for most arms, docetaxel also required for cabazitaxel arm. Exclude: active autoimmune disease on immunosuppression, unresolved ≥Grade 2 toxicity, prior transplant, drug allergies, major infections/serious conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1b, dose-escalation/expansion trial in metastatic prostate cancer testing JNJ-78278343—a T-cell–redirecting biologic targeting human kallikrein-2 (KLK2)—combined with: cetrelimab (anti–PD-1 monoclonal antibody), cabazitaxel or docetaxel (taxane microtubule inhibitors), or androgen receptor pathway inhibitors (ARPIs: apalutamide, enzalutamide, darolutamide—AR antagonists, abiraterone acetate + prednisone—CYP17A1 inhibitor + steroid). Mechanisms: JNJ-78278343 redirects T cells to lyse KLK2-expressing tumor cells, cetrelimab blocks PD-1 to restore T-cell activity, taxanes disrupt microtubules/mitosis, ARPIs inhibit AR signaling or androgen synthesis (abiraterone). Targets: tumor KLK2, T-cell cytotoxicity/checkpoints, microtubules, androgen receptor axis.