N=~663
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Key eligibility criteria*:
- Histologically confirmed mCRPC
- PSA ≥2 ng/mL
- No prior treatment with any CD3-directed therapy
- Prior treatment with:
- ≥1 ARPI
- ≥2 taxane-based regimens†
- ≥1 dose of PSMA-targeted lutetium radioligand therapy
- PARPi if known germline or somatic BRCAm
Primary outcome:
- OS
Secondary outcomes:
- rPFS
- Time to symptomatic progression
- Time to skeletal-related event
- Time to deterioration in fatigue
- PFS
- Time to PSA progression
- Time to pain progression
- AEs
- Abnormalities in clinical laboratory assessments
*Not a complete list of inclusion and exclusion criteria. †If a participant has received only 1 taxane regimen, the participant is eligible if cabazitaxel is not available, the participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk, or prior intolerance. Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period. ‡Best supportive care is defined as palliative external beam radiation, low-dose steroid therapy, pain medication, bone-sparing agents, and needed palliative procedures.
AE, adverse event; ARPI, androgen receptor pathway inhibitor; BRCAm, breast cancer gene mutation; CD, cluster of differentiation; IV, intravenous; KLK2, human kallikrein-2; mCRPC, metastatic castration-resistant prostate cancer; OS, overall survival; PARPi, poly (ADP-ribose) polymerase inhibitor; PFS, progression-free survival; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; rPFS, radiographic progression-free survival.