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
Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in combination with best supportive care (BSC) as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria * Histologically confirmed adenocarcinoma of the prostate * Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (chest, abdomen, and pelvis) and 99m\^Tc bone scan * PSA greater than or equal to (\>=) 2 nanogram per milliliter (ng/mL) at screening * In the opinion of the investigator, the next best treatment option is a clinical trial * Partic…
Interventions
- BiologicalPasritamig
Pasritamig will be administrated through IV infusion.
- OtherPlacebo
Placebo will be administrated through IV infusion.
- DrugBest Supportive Care (BSC)
BSC will be administered at the discretion of the treating physician.
Locations (166)
- University of California at San DiegoLa Jolla, California
- Ronald Reagan UCLA Medical CenterLos Angeles, California
- Rocky Mountain Cancer CentersAurora, Colorado
- University of Colorado Cancer CenterAurora, Colorado
- Colorado Clinical ResearchLakewood, Colorado
- Hartford HospitalHartford, Connecticut