A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy
The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy [ARDT]).
Inclusion Criteria:
Participant has provided informed consent prior to initiation of any study-specific activities/procedures.
Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days prior to enrollment.
Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
Participants must have had a prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
Prior progression on at least one ARDT (enzalutamide, abiraterone, apalutamide, darolutamide).
Prior treatment with only one taxane therapy in the mCRPC setting. Note: Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting.
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Adequate organ function.
Life expectancy of ≥ 12 weeks per the treating physician's assessment.
Key Exclusion Criteria:
Prior & Concomitant Therapy:
Disease Related:
Louisville, Kentucky 40202, United States
Kashiwa-shi, Chiba 277-8577, Japan
Sagamihara-shi, Kanagawa 252-0375, Japan
Suita-shi, Osaka 565-0871, Japan
Hidaka-shi, Saitama 350-1298, Japan
Koshigaya-shi, Saitama 343-8555, Japan
Bunkyo-ku, Tokyo 113-8603, Japan
Koto-ku, Tokyo 135-8550, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Goyang-si, Gyeonggi-do, 10408, South Korea
Seongnam-si, Gyeonggi-do, 13620, South Korea