8343PCR1003
Prostate cancer
A Phase 1b study of pasritamig (KLK2 × CD3 bispecific antibody) in combination with cetrelimab, taxanechemotherapy or ARPIs in participants with metastatic prostate cancer
Phase
b
Compound
Pasritamig (KLK2 × CD3 bispecific Ab) + cetrelimab (anti–PD-1 mAb), taxane chemotherapy or ARPIs
NCT identifier
NCT05818683
Enrollment
N=~277
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contact details, please visit
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contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- Parts 1A–G and 2B–G: mCRPC with confirmed adenocarcinoma of the prostate as defined by PCWG3
- Measurable or evaluable disease
- 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 and 2C–G: prior treatment with ≥1 prior ARPI
- Part 2H: mCSPC with no prior cytotoxic chemotherapy
- ECOG PS 0 or 1
- Adequate organ functions
- No solid organ or bone marrow transplantation
Study
design
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.
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; mCSPC, metastatic castration-sensitive prostate cancer; ORR, overall response rate; PCWG3, Prostate Cancer Working Group 3; PFS, progression-free survival; PSA, prostate-specific antigen; RP2R, recommended Phase 2 regimen; rPFS, radiographic progression-free survival; TTR, time to response.