Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Registration Number
- NCT06691984
- Lead Sponsor
- Amgen
- Brief Summary
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 \[ARDT\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 675
-
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.
-
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.
- Progression of bone disease: evaluable disease or new bone lesion(s) by bone scan (2+2 PCWG3 criteria, Scher et al, 2016).
-
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 treatment with at least one ARDT.
-
Prior treatment with one taxane therapy. Prior treatment with docetaxel in the hormone-sensitive setting is permitted. Participants who received two or more prior chemotherapy regimens in the castrate-resistant setting are not eligible.
-
Prior treatment with radioligand therapy (RLT), radionuclide therapy (Radium-223), poly ADP-ribose polymerase (PARP) inhibitor, or immune checkpoint inhibitor is permitted.
-
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
-
Adequate organ function.
Key
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 suppression therapy.
- Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 2 months of the first dose of study treatment unless participants received < 2 cycles of therapy. Participants who received 1 cycle of PSMA RLT within 35 days prior to the first dose of study treatment are also excluded.
- Participants who started a bisphosphonate or denosumab regimen within 4 weeks prior to the first dose of study treatment.
- Radiation therapy within 4 weeks prior to the first dose of study treatment (or local or focal radiotherapy within 2 weeks prior to the first dose of study treatment).
- Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, or investigational therapy.
Disease Related:
- Participants with a history of central nervous system (CNS) metastasis.
- Unresolved toxicities from prior anti-tumor therapy with 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Xaluritamig Xaluritamig Participants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion. Cabazitaxel/Abiraterone/Enzalutamide Abiraterone 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. Cabazitaxel/Abiraterone/Enzalutamide 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. Cabazitaxel/Abiraterone/Enzalutamide Cabazitaxel 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.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 43 months
- Secondary Outcome Measures
Name Time Method Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Up to approximately 43 months Change from Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Score Baseline and approximately 43 months Change from Baseline in BPI-SF Pain Intensity Scale Score Baseline and approximately 43 months Change from Baseline in BPI-SF Pain Interference Scale Score Baseline and approximately 43 months Time to First Symptomatic Skeletal Events (SSE) Up to approximately 43 months Time to Response (TTR) per RECIST v1.1 as Assessed by BICR Up to approximately 43 months Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR) Up to approximately 43 months Objective Response Rate per RECIST v1.1 as Assessed by BICR Up to approximately 43 months Duration of Response (DOR) per RECIST v1.1 as Assessed by BICR Up to approximately 43 months Disease Control Rate Up to approximately 43 months Progression-free Survival (PFS) Up to approximately 43 months Change from baseline in the European Quality of Life 5 Domain 5 Level Scale (EQ-5D-5L) Visual Analogue Scale (VAS) Baseline and approximately 43 months Change from Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score Baseline and approximately 43 months Time to Worsening in BPI-SF Worst Pain Score Up to approximately 43 months Time to Worsening in BPI-SF Pain Intensity Scale Score Up to approximately 43 months Time to Worsening in BPI-SF Pain Interference Scale Score Up to approximately 43 months Time to Worsening in FACT-P Total Score Up to approximately 43 months Time to Pain Improvement in Participants with Moderate/Severe Pain at Baseline Up to approximately 43 months Time to Pain Improvement after Worsening in BPI-SF Pain Intensity Scale Score Up to approximately 43 months Time to Pain Improvement after Worsening in BPI-SF Pain Interference Scale Up to approximately 43 months Number of Patient-Reported Symptomatic AEs per Patient-reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library Up to approximately 43 months Patient-Reported Summary Scores for Overall Bother of Side Effects per FACT-P Up to approximately 43 months Percentage of Participants Achieving a ≥50% Reduction in Prostate-specific Antigen (PSA) (PSA50) Up to approximately 43 months Percentage of Participants Achieving a ≥90% Reduction in PSA (PSA90) Up to approximately 43 months Maximum Serum Concentration (Cmax) of Xaluritamig Up to approximately 43 months Time to Cmax (Tmax) of Xaluritamig Up to approximately 43 months Minimum Serum Concentration (Cmin) of Xaluritamig Up to approximately 43 months Area Under the Concentration-time Curve (AUC) of Xaluritamig Up to approximately 43 months Accumulation Following Multiple Dosing of Xaluritamig Up to approximately 43 months Half-life (t1/2) of Xaluritamig Up to approximately 43 months Number of Participants with Anti-xaluritamig Antibody Up to approximately 43 months
Trial Locations
- Locations (55)
Sir Mortimer B Davis - Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Vejle Sygehus
🇩🇰Vejle, Denmark
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Providence Saint Jude Medical Center
🇺🇸Fullerton, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
University of California Irvine
🇺🇸Irvine, California, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Sanford Oncology Clinic and Pharmacy
🇺🇸Sioux Falls, South Dakota, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Chris OBrien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Macquarie University
🇦🇺North Ryde, New South Wales, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
The Alfred Hospital
🇦🇺Warrnambool, Victoria, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
🇧🇪Kortrijk, Belgium
BC Cancer Vancouver
🇨🇦Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Athens Medical Center S.A - Iatriko Amarousiou
🇬🇷Athens, Greece
European Interbalkan Medical Center
🇬🇷Thessaloniki, Greece
Queen Mary Hospital, The University of Hong Kong
🇭🇰Hong Kong, Hong Kong
Nagoya University Hospital
🇯🇵Nagoya-shi, Aichi, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama-shi, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo-shi, Hokkaido, Japan
Yokohama City University Medical Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Osaka International Cancer Institute
🇯🇵Osaka-shi, Osaka, Japan
The University of Osaka Hospital
🇯🇵Suita-shi, Osaka, Japan
The Cancer institute Hospital of Japanese Foundation for Cancer Research
🇯🇵Koto-ku, Tokyo, Japan
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Radboud Universitair Medisch Centrum
🇳🇱Nijmegen, Netherlands
National University Hospital
🇸🇬Singapore, Singapore
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Cataluña, Spain
HOCH Health Ostschweiz
🇨🇭Sankt Gallen, Switzerland
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Izmir Medical Point Hastanesi
🇹🇷Izmir, Turkey
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Guys Hospital
🇬🇧London, United Kingdom
Sarah Cannon Research Institute UK
🇬🇧London, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom