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Compares treatment options for Metastatic Castration-resistant Prostate Cancer
Official title A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07213674
What this study is testing
What is Xaluritamig?
Xaluritamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Also referred to as AMG 509.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic...
- Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria:
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Goodyear, Arizona, United States
- Duarte, California, United States
- Fullerton, California, United States
- Orange, California, United States
- Santa Monica, California, United States
- Denver, Colorado, United States
- Newark, Delaware, United States
- Tampa, Florida, United States
- Newnan, Georgia, United States
- Chicago, Illinois, United States
- Zion, Illinois, United States
- Westwood, Kansas, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Lansing, Michigan, United States
- Minneapolis, Minnesota, United States
- East Syracuse, New York, United States
- Cincinnati, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Pittsburgh, Pennsylvania, United States
+ 96 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goodyear, Arizona, United States; Duarte, California, United States; Fullerton, California, United States; Orange, California, United States; Santa Monica, California, United States; Denver, Colorado, United States and 110 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.