A Phase III, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

Study Identifier:
20230239
CT.gov Identifier:
NCT07213674
EudraCT Identifier:
202552055589
EU Trial (CTIS) Number:
2025-520555-89-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).

To study xaluritamig plus abiraterone vs investigator’s choice in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC).

To compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone)

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Prostate
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase III
Sex
Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • Participant has provided informed consent before 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.
  • Metastatic castration-resistant prostate cancer (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 before enrollment.
  • 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(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria).
  • 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).
  • Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required.
  • Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Adequate organ function.
  • CTIS
  • Participant has provided informed consent before initiation of any study-specific activities/procedures
  • Adequate organ function
  • Age greater than or equal to 18 years (or greater than or equal to 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 greater than or equal to 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment
  • Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria
  • Participants must have had prior orchiectomy and/or ongoing androgren-deprivation therapy (ADT) and a castrate level of serum testosterone (less than 50 ng/dL or less than 1.7 nmol/L)
  • Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required
  • Participants intended to receive cabazitaxel must have previously received less than or equal to 6 cycles of docetaxel in the mHSPC setting
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Exclusion criteria
  • Disease Related:
  • Participants with a history of central nervous system (CNS) metastases.
  • 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:
  • Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
  • Prior disease progression on or intolerance to abiraterone.
  • Prior treatment with any chemotherapy regimen in the mCRPC setting and/or > 6 cycles of docetaxel treatment in the mHSPC setting.
  • Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions:
  • Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment.
  • Androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotrophin releasing hormone [LHRH/GnRH] analogue [agonist/antagonist]) is permitted.
  • Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment.
  • Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment.
  • Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities.
  • Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy.
  • Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.
  • Prior CD3-directed therapy.
  • CTIS
  • Participants with a history of central nervous system (CNS) metastases
  • Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment
  • Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities
  • Prior CD3-directed therapy
  • Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy
  • Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment
  • 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 six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy
  • Prior disease progression on or intolerance to abiraterone
  • Prior treatment with any chemotherapy regimen in the mCRPC setting and/or greater than 6 cycles of docetaxel treatment in the mHSPC setting
  • Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions: Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment Androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotropin releasing hormone [LHRH/GnRH] analogue [agonist/antagonist]) is permitted
  • Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Recruiting
Condition(s) Treated at Site
Prostate