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Pasritamig with or without JNJ-87189401 in Late-line mCRPC
NCT07164443Phase 3
Key facts
- Status
- Recruiting
- Start
- Sep 2025
- Primary completion
- Aug 2028
- Countries
- 17
- Sponsor
- Janssen Pharmaceutical
- Modality
- Antibody Conjugates, Bispecific Antibodies, Monoclonal Antibodies
- Drugs
- pasritamig
- Conditions
- metastatic castration-resistant prostate cancer (mCRPC)
01
Overview
Phase 3, randomised, double-blind trial of pasritamig in metastatic castration-resistant prostate cancer (mCRPC) (5 arms), sponsored by Janssen Pharmaceutical. Primary endpoint: Overall Survival. Started Sep 2025; status: recruiting.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Part 1: Pasritamig+Best Supportive Care (BSC)
2 step-up doses of pasritamig IV followed by target dose + BSC
Part 1: Placebo+BSC
2 step-up doses of placebo IV followed by target dose + BSC
Part 2: Pasritamig+BSC
2 step-up doses of pasritamig IV followed by target dose + BSC
Part 2: Pasritamig+JNJ-87189401+BSC
2 step-up doses of pasritamig IV followed by target dose + JNJ-87189401 + BSC
Part 2: Placebo +BSC
2 step-up doses of placebo IV followed by target dose + BSC
03
Who it enrols
Patients with mCRPC who have progressed on prior ARPI, taxanes, radioligand therapy, and PARPi (if applicable), with adequate organ function and ECOG PS 0-2.
04
Endpoints
Primary
Overall Survival
Secondary
Radiographic Progression-free Survival
Time to Symptomatic Progression
Time to Skeletal-Related Event
Progression-Free Survival
Time to Prostate Specific Antigen Progression
Time to Pain Progression
Time to Deterioration in Fatigue
Number of Participants with Adverse Events
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