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Tests treatment safety and results for Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Official title Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
ClinicalTrials.gov ID: NCT07140900
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 hormone-sensitive prostate cancer (mhspc).
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 main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
- Phase 1: an early, usually small safety 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
- Participants must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg...
- Participants must have at the time of diagnosis:
- De novo (synchronous) mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer, AND started ADT (LHRH...
- Participants must have at the time of diagnosis:
- High-volume metastatic disease defined as presence of visceral metastasis or metastases, and/or ≥ 4 bone metastases with at least one outside of the...
You likely can't join if
- Prior history of central nervous system (CNS) metastases. Note: Participants with asymptomatic and clinically stable dural metastases are eligible.
- Unresolved toxicities from prior anti-tumor therapy (excluding those related to ongoing ADT and ARPI) not having resolved to Common Terminology...
- Autoimmune disease requiring systemic immunosuppression within the past 2 years.
- Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active or systemic infection...
- Prior six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
- Prior radioligand therapy (RLT), poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, cytotoxic chemotherapy, aminoglutethimide or...
See the full eligibility criteria
- Participants must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
- Participants must have at the time of diagnosis:
- De novo (synchronous) mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer, AND started ADT (LHRH agonist/antagonist or orchiectomy) with or without ARPI (defined as abiraterone OR...
- Participants must have at the time of diagnosis:
- High-volume metastatic disease defined as presence of visceral metastasis or metastases, and/or ≥ 4 bone metastases with at least one outside of the vertebral column and pelvis.
- Documented metastatic disease either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI)...
- No documented PSA progression following the initial PSA nadir after starting ADT.
- Prior history of central nervous system (CNS) metastases. Note: Participants with asymptomatic and clinically stable dural metastases are eligible.
- Unresolved toxicities from prior anti-tumor therapy (excluding those related to ongoing ADT and ARPI) not having resolved to Common Terminology Criteria for Adverse events (CTCAE) version 5.0 grade 1 or baseline, with...
- Autoimmune disease requiring systemic immunosuppression within the past 2 years.
- Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active or systemic infection within 7 days prior to the first dose of study treatment.
- Prior six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
- Prior radioligand therapy (RLT), poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, cytotoxic chemotherapy, aminoglutethimide or ketoconazole for prostate cancer, or any prior systemic biologic therapy...
- Prior enzalutamide or apalutamide within 15 days prior to enrolment.
- Requirement for chronic systemic corticosteroid therapy (prednisone dose greater than 10 mg per day or local equivalent) or any other immunosuppressive therapies (including anti TNFα therapies) unless stopped (with...
- Prior radiotherapy to all metastatic sites of disease. Radiotherapy to some sites of metastatic disease for palliation will be permitted.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Camperdown, New South Wales, Australia
- Waratah, New South Wales, Australia
- Clayton, Victoria, Australia
- Melbourne, Victoria, Australia
- Chur, Switzerland
- Lausanne, Switzerland
- Sankt Gallen, Switzerland
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 San Francisco, California, United States; Boston, Massachusetts, United States; Minneapolis, Minnesota, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States; Pittsburgh, Pennsylvania, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.