78278343PBPCR1005
Prostate cancer
A Phase 1b, nonrandomized, open-label study of pasritamig (JNJ-78278343; KLK2 × CD3 bispecific Ab) in combination with JNJ-86974680 (adenosine 2a receptor antagonist) in participants with mCRPC
Phase
b
Compound
Pasritamig (JNJ-78278343; KLK2 × CD3 bispecific Ab) + JNJ-86974680 (adenosine 2a receptor antagonist)
NCT identifier
NCT07319871
Enrollment
N=~40
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Study overview & design
Key eligibility criteria*:
- mCRPC with histologic confirmation of adenocarcinoma
- Measurable or evaluable disease
- PSA ≥2 ng/mL at screening
- Prior orchiectomy or medical castration; or receiving ongoing ADT with a GnRH analogue
- ECOG PS 0 or 1
- No leptomeningeal disease or brain metastases
Study
design
Primary outcomes†:
- Safety
- DLT
Secondary outcomes†:
- ORR
- PSA response rate
- DOR
- rPFS
- TTR
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of outcomes.
Ab, antibody; ADT, androgen deprivation therapy; CD, cluster of differentiation; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GnRH, gonadotropin-releasing hormone; KLK2, human kallikrein-2; IV, intravenous; mCRPC, metastatic castration-resistant prostate cancer; ORR, objective response rate; PO, orally; PSA, prostate-specific antigen; RP2CD, recommended Phase 2 combination dose; rPFS, radiographic progression-free survival; TTR, time to response.