N=~355
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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
- ECOG PS 0 or 1
- Part 1, 2A, 2B, 3, and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing ADT with GnRHa
Primary outcomes:
- DLTs (Part 1, 2C, 3, and 4)
- AEs by severity
Secondary outcomes:
- Serum concentration of JNJ-87189401 and pasritamig (JNJ-78278343)
- Plasma Concentration of JNJ-101556143
- ADAs
- ORR
- 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. ‡Participants with different disease settings in Parts 2A and 2B
will receive pasritamig (JNJ-78278343) + JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will
receive apalutamide plus continued treatment with JNJ-87189401 + pasritamig (JNJ-78278343) doublet.
Ab, antibody;
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; ORR, objective response rate; PCWG3, Prostate Cancer Working Group 3; PSA, prostate-specific
antigen; PSMA, prostate-specific membrane antigen; RP2R, recommended Phase 2 dose; rPFS, radiographic
progression-free survival.