N=~300
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Key eligibility criteria*:
- Parts 1A–G, 1I–1K, and 2B–C: mCRPC with confirmed adenocarcinoma of the prostate as defined by PCWG3
- Parts 2D–G and 2I–K: mCRPC: histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 ng/mL
- Part 2H: mHSPC with PSA >0.2 ng/mL on 6–24 months of next generation ARPI treatment
- Measurable or evaluable disease, except for Part 2H
- Part 1A: prior treatment for mCRPC with ≥1 prior ARPI, or chemotherapy
- Parts 1B and 2B: prior treatment with ≥1 prior ARPI and docetaxel
- Parts 1C–G, 1I–K, 2C–G, 2I–K: prior treatment with ≥1 prior ARPI
- Parts 1I, 1J, 2I, and 2J: must not have received prior cytotoxic chemotherapy or prior RLT for mCRPC
- Part 2H: may have received up to 6 cycles of docetaxel
- ECOG PS 0 or 1
- Adequate organ functions
- No solid organ or bone marrow transplantation
Primary outcomes:
- DLTs (Part 1)
- AEs (Parts 1 and 2)
Secondary outcomes:
- ORR
- rPFS
- TTR
- PSA response rate
- DOR
- Part 2H: composite PFS
*Not a complete list of inclusion and exclusion criteria. †The dose of pasritamig will be escalated sequentially until a RP2R. ‡Cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, darolutamide, abiraterone acetate plus prednisone, lutetium Lu-177 vipivotide tetraxetan and JNJ-101556143.
Ab, antibody; AE, adverse event; ARPI, androgen receptor pathway inhibitor; CD, cluster of differentiation; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; KLK2, human kallikrein-2; mCRPC, metastatic castration-resistant prostate cancer; mHSPC, metastatic hormone-sensitive prostate cancer; ORR, overall response rate; PCWG3, Prostate Cancer Working Group 3; PFS, progression-free survival; PSA, prostate-specific antigen; RLT, radioligand therapy; RP2D, recommended Phase 2 dose; rPFS, radiographic progression-free survival; TTR, time to response.