USO 24292
Trial Number: 78278343PCR3001 (KLK2-comPAS) Protocol Title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T cell redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer.
Disease Types: Genitourinary Cancer Research
Eligibility Requirements:
• Histologically confirmed metastatic CRPC
• ECOG ≤ 2
• Subjects must have a PSA ≥2 ng/mL at screening
• Must have received all available life-prolonging therapies:
• ARPI: Progressed on ≥1; no benefit expected from another
• Taxanes: ≥2 regimens; if only 1, cabazitaxel unavailable or unsuitable
• Radioligand: ≥1 PSMA-targeted dose unless unavailable or unsuitable
• PARPi: Required if BRCA mutation and therapy available
• Subjects must have prior orchiectomy or ongoing medical castration with a
GnRH analog and continue ADT throughout treatment
• Subjects that received prior CD3-directed therapy are excluded
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