Metastatic Castration-resistant Prostate Cancer
Conditions
Interventions
Experimental: Xaluritamig Plus Abiraterone
- Participants will be randomized to receive xaluritamig in combination withabiraterone acetate.
- Interventions:
Drug: Xaluritamig
Drug: Abiratero
Sponsors
Tagashira Shuzo
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Participant has provided informed consent before initiation of any study-specific activities/procedures. 2. Age >= 18 years (or >= legal age within the country if it is older than 18 years) at the time of signing the informed consent. 3. Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted. 4. Metastatic castration-resistant prostate cancer (mCRPC) with >= 1 metastatic lesion thatis present on baseline computed tomography (CT), magnetic resonance imaging (MRI),or bone scan imaging obtained within 28 days before enrollment. 5. Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria: - Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng/mL. - Soft-tissue progression defined as an increase >= 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions. - Progression of bone disease defined by the appearance of at least 2 new bone lesions by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria). 6. Participants must have had prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L). 7. Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI)(either enzalutamide, apalutamide, or darolutamide) is required. 8. Participants intended to receive cabazitaxel must have previously received <= 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting. 9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 10. Adequate organ function.
Exclusion criteria
Exclusion criteria: Disease Related: 1. Participants with a history of central nervous system (CNS) metastases. 2. Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor. Prior/Concomitant Therapy: 3. Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy. 4. Prior disease progression on or intolerance to abiraterone. 5. Prior treatment with any chemotherapy regimen in the mCRPC setting and/or > 6 cycles of docetaxel treatment in the mHSPC setting. 6. Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment, not including androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotropin releasing hormone [LHRH/GnRH] analogue [agonist/antagonist]). 7. Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 3months of first dose of study treatment. Participants who received < 2 cycles of PSMARLT within 6 weeks of first dose of study treatment are also excluded. 8. Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment. 9. Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities. 10. Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy. 11. Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. OS [Time Frame: Up to approximately 50 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group 3(PCWG3)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Per Investigator Assessment [Time Frame: Up to approximately 82 months] 2. Objective Response per Modified RECIST 1.1, Per Investigator Assessment [Time Frame: Up to approximately 82 months] 3. Duration of Response (DOR) Per Modified RECIST 1.1, Per Investigator Assessment [Time Frame: Up to approximately 82 months] 4. Disease Control Per Modified RECIST 1.1, Per Investigator Assessment [Time Frame: Up to approximately 82 months] 5. Progression-free Survival (PFS) 2, Per Investigator Assessment [Time Frame: Up to approximately 82 months] 6. Time to Response (TTR), Per Modified RECIST 1.1, Per Investigator Assessment [Time Frame: Up to approximately 82 months] 7. Time to First Subsequent Therapy [Time Frame: Up to approximately 82 months] 8. Time to Symptomatic Skeletal Events (SSE) [Time Frame: Up to approximately 82 months] 9. Number of Participants With Treatment-emergent Adverse events, Treatment-emergent Serious Adverse Events, and Fatal Adverse Events [Time Frame: Up to approximately 82months] 10. Change From Baseline Over Time at Each Assessment in Brief Pain Inventory - Short Form (BPI-SF) Pain Intensity Scale [Time Frame: From baseline up to approximately 22 months] 11. Change From Baseline Over Time at Each Assessment in BPI-SF Worst Pain Score [Time Frame: From baseline up to approximately 22 months] 12. Change From Baseline Over Time at Each Assessment in BPI-SF Pain Interference Scale [Time Frame: From baseline up to approximately 22 months] 13. Change From Baseline Over Time at Each Assessment in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score and Subscale Scores [Time Frame: From baseline up to approximately 22 months] 14. Change From Baseline Over Time at Each Assessment in European Quality of Life (EuroQol) 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score [Ti | — |
Countries
Japan, United Kingdom, United States
Contacts
Public ContactContact Local
Amgen K.K.
Outcome results
None listed