9401PCR1001
Prostate cancer
A Phase 1 study of JNJ-87189401 (PSMA × CD28 bispecific antibody) in combination with pasritamig (KLK2 × CD3 bispecific antibody) in participants with mCRPC
Phase
Compound
JNJ-87189401 (PSMA × CD28 bispecific Ab) + pasritamig (KLK2 × CD3 bispecific Ab)
NCT identifier
NCT06095089
Enrollment
N=~250
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- mCRPC with confirmed adenocarcinoma of the prostate; adenocarcinoma with small cell or neuroendocrine features is permitted
- Measurable or evaluable disease per PCWG3
- Prior orchiectomy or medical castration or ongoing ADT with GnRHa
- ECOG PS 0 or 1
Study
design
Primary outcomes:
- DLTs (Part 1)
- AEs (Parts 1 and 2)
Secondary outcomes:
- Serum concentration of JNJ-87189401 (Part 2)
- ADAs
- Objective response rate
- rPFS
- PSA response rate
- DOR
*Not a complete list of inclusion and exclusion criteria. †The doses of pasritamig + JNJ-87189401 will be escalated sequentially until a RP2R.
ADA, antidrug antibody; ADT, androgen deprivation therapy; AE, adverse event; CD, cluster of differentiation; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GnRHa, gonadotropin-releasing hormone analog; KLK2, human kallikrein-2; mCRPC, metastatic castration-resistant prostate cancer; PCWG3, Prostate Cancer Working Group 3; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; RP2R, recommended Phase 2 regimen; rPFS, radiographic progression-free survival.