Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Phase 1NCT07140900
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
A Phase 1 study testing Xaluritamig, Darolutamide and Abiraterone in people with Metastatic Hormone-sensitive Prostate Cancer (mHSPC), run by Amgen at 16 sites in 3 countries.
Trial summary
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- What is being tested?
- Xaluritamig, Darolutamide and Abiraterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 7 Oct 2025to 30 Mar 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 darolutamide) as SOC, first treatment with ADT should be no longer than 12 weeks before screening. Prior docetaxel treatment is not permitted.
- 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) scan.
- No documented PSA progression following the initial PSA nadir after starting ADT.
Who cannot join
- 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 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.
- 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, including immunotherapy for prostate cancer.
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- 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 adequate tapering) within 7 days prior to dosing.
- Prior radiotherapy to all metastatic sites of disease. Radiotherapy to some sites of metastatic disease for palliation will be permitted.
Trial locations and contacts
16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 3 countries
United States8 sites, 8 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
South Texas Accelerated Research Therapeutics - Carolinas
Myrtle Beach, South Carolina, 29572
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Recruiting
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Australia5 sites, 5 recruiting
- Recruiting
Chris OBrien Lifehouse
Camperdown, New South Wales, 2050
- Recruiting
Cabrini Hospital
Clayton, Victoria, 3168
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
- Recruiting
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298
Switzerland3 sites, 3 recruiting
- Recruiting
Kantonsspital Graubuenden
Chur, 7000
- Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
- Recruiting
Kantonsspital Sankt Gallen
Sankt Gallen, 9007
About this study
Official title: A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
- Being tested
- Xaluritamig, Darolutamide, Abiraterone
- Keywords
- Prostate cancer, Xaluritamig
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XaluritamigDrug
Also called AMG 509
Participants will receive xaluritamig intravenously.
DarolutamideDrug
Participants will receive darolutamide orally.
AbirateroneDrug
Participants will receive abiraterone orally.
| Study group | Role | What they receive |
|---|---|---|
| Xaluritamig with Darolutamide | Experimental | Participants will receive xaluritamig in combination with darolutamide. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first. Receives: Drug: Xaluritamig; Drug: Darolutamide |
| Xaluritamig with Abiraterone | Experimental | Participants will receive xaluritamig in combination with abiraterone. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first. Receives: Drug: Xaluritamig; Drug: Abiraterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events
Measured: Up to approximately 2.5 years
Number of Participants with Treatment-related Adverse Events
Measured: Up to approximately 2.5 years
Number of Participants with Clinically Significant Changes in Vital Signs
Measured: Up to approximately 2.5 years
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Measured: Up to approximately 2.5 years
Secondary outcomes (10)
Percentage of Participants with Prostate-specific Antigen (PSA) < 0.2 ng/mL at 6 Months
Measured: 6 months
Time to PSA Progression
Measured: Up to approximately 4.5 years
Time to First New Systemic Anticancer Therapy
Measured: Up to approximately 4.5 years
Time to Radiographic Progression per Prostate Cancer Working Group 3 (PCWG3) Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: Up to approximately 4.5 years
Observed Concentration at the End of a Dose Interval of Darolutamide
Measured: Up to approximately 4.5 years
Observed Concentration at the End of a Dose Interval of Abiraterone
Measured: Up to approximately 4.5 years
Maximum Observed Serum Concentration (Cmax) of Xaluritmag
Measured: Up to approximately 4.5 years
Time to Cmax (Tmax) of Xaluritmag
Measured: Up to approximately 4.5 years
Area Under the Concentration Time Curve (AUC) of Xaluritmag
Measured: Up to approximately 4.5 years
Half-life (t1/2) of Xaluritamig
Measured: Up to approximately 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start7 Oct 2025
- Primary completion27 Mar 2028 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Studies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140900
- Sponsor's protocol ID
- 20240361
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Open-label, Multicenter 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
- Acronym / sponsor ID
- 20240361
- Keywords
- Prostate cancer, Xaluritamig
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 27 Mar 2028 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xaluritamig with Darolutamide | Experimental | Drug: Xaluritamig, Drug: DarolutamideParticipants will receive xaluritamig in combination with darolutamide. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first. |
| Xaluritamig with Abiraterone | Experimental | Drug: Xaluritamig, Drug: AbirateroneParticipants will receive xaluritamig in combination with abiraterone. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Participants must have at the time of diagnosis:
- 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) scan.
- No documented PSA progression following the initial PSA nadir after starting ADT.
Key exclusion criteria (9 listed)
- 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 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XaluritamigAlso: AMG 509Participants will receive xaluritamig intravenously. | Drug | Xaluritamig with Abiraterone, Xaluritamig with Darolutamide |
| DarolutamideParticipants will receive darolutamide orally. | Drug | Xaluritamig with Darolutamide |
| AbirateroneParticipants will receive abiraterone orally. | Drug | Xaluritamig with Abiraterone |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to approximately 2.5 years
Number of Participants with Treatment-related Adverse Events
Time frame: Up to approximately 2.5 years
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to approximately 2.5 years
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame: Up to approximately 2.5 years
10 secondary outcomes
Percentage of Participants with Prostate-specific Antigen (PSA) < 0.2 ng/mL at 6 Months
Time frame: 6 months
Time to PSA Progression
Time frame: Up to approximately 4.5 years
Time to First New Systemic Anticancer Therapy
Time frame: Up to approximately 4.5 years
Time to Radiographic Progression per Prostate Cancer Working Group 3 (PCWG3) Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to approximately 4.5 years
Observed Concentration at the End of a Dose Interval of Darolutamide
Time frame: Up to approximately 4.5 years
Observed Concentration at the End of a Dose Interval of Abiraterone
Time frame: Up to approximately 4.5 years
Maximum Observed Serum Concentration (Cmax) of Xaluritmag
Time frame: Up to approximately 4.5 years
Time to Cmax (Tmax) of Xaluritmag
Time frame: Up to approximately 4.5 years
Area Under the Concentration Time Curve (AUC) of Xaluritmag
Time frame: Up to approximately 4.5 years
Half-life (t1/2) of Xaluritamig
Time frame: Up to approximately 4.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xaluritamig, Darolutamide and Abiraterone in people with Metastatic Hormone-sensitive Prostate Cancer (mHSPC), run by Amgen at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Australia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (time frame: Up to approximately 2.5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.