Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)
Purpose
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]).
Condition
- Metastatic Castration-resistant Prostate Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
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: - Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal 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 one 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 lesion(s) by bone scan (as per the 2+2 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.
Exclusion Criteria
Prior & Concomitant Therapy: - Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy. - Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to the first dose of study treatment, not including androgen receptor pathway inhibitors (ARPIs) (abiraterone, enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment and androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotropin-releasing hormone [LHRH/GnRH] analogue [agonist/antagonist]). - Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 3 months of the first dose of study treatment unless participants received < 2 cycles of therapy. - Prior palliative radiotherapy within 2 weeks of first dose of study treatment. Participants must have recovered from all radiation-related toxicities. - Concurrent cytotoxic chemotherapy, ARDT, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, investigational therapy. Note: Prior treatment with a PARP inhibitor is permitted as long as not within 4 weeks before first dose of study treatment. - Prior radionuclide therapy (Radium-223) within 2 months of first dose of study treatment. - Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment. Disease Related: - Participants with a history of central nervous system (CNS) metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible. - Unresolved toxicities from prior anti-tumor therapy not having resolved to CTCAE version 5.0 events grade above 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Xaluritamig |
Participants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion. |
|
|
Active Comparator Cabazitaxel/Abiraterone/Enzalutamide |
Participants with mCRPC will be randomized to receive cabazitaxel as an IV infusion, or a second androgen receptor-directed therapy of either abiraterone as oral tablets, or enzalutamide as oral tablets at the investigator's discretion. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35233
Duarte 5344147, California 5332921 91010
Fullerton 5351247, California 5332921 92835
Los Angeles 5368361, California 5332921 90048
Orange 5379513, California 5332921 92868
San Francisco 5391959, California 5332921 94158
Gainesville 4156404, Florida 4155751 32610
Miami 4164138, Florida 4155751 33136
Orlando 4167147, Florida 4155751 32804
Chicago 4887398, Illinois 4896861 60637
Indianapolis 4259418, Indiana 4921868 46202
Louisville 4299276, Kentucky 6254925 40202
Louisville 4299276, Kentucky 6254925 40207
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
Detroit 4990729, Michigan 5001836 48202
Minneapolis 5037649, Minnesota 5037779 55455
St Louis 4407066, Missouri 4398678 63110
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10065
The Bronx 5110266, New York 5128638 10467
Charlotte 4460243, North Carolina 4482348 28204
Durham 4464368, North Carolina 4482348 27710
Fargo 5059163, North Dakota 5690763 58122
Cleveland 5150529, Ohio 5165418 44195
Columbus 4509177, Ohio 5165418 43210
Portland 5746545, Oregon 5744337 97239
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19111
Pittsburgh 5206379, Pennsylvania 6254927 15232
Sioux Falls 5231851, South Dakota 5769223 57104
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
Dallas 4684888, Texas 4736286 75390
Houston 4699066, Texas 4736286 77030
Murray 5778755, Utah 5549030 84107
Norfolk 4776222, Virginia 6254928 23502
Seattle 5809844, Washington 5815135 98019-1024
Seattle 5809844, Washington 5815135 98104
Madison 5261457, Wisconsin 5279468 53705
Milwaukee 5263045, Wisconsin 5279468 53226
More Details
- Status
- Recruiting
- Sponsor
- Amgen