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Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 1NCT07493512

Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer

A Phase 1 study testing Xaluritamig in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by Amgen at 14 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The primary objective of this trial is to determine the safety profile of xaluritamig at the proposed regimen in adult participants with metastatic castration-resistant prostate cancer (mCRPC). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Xaluritamig
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
14 sitesin 2 countries
Study dates
28 Apr 2026to 30 Jul 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

  • Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
  • mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scintigraphy 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% and an absolute increase of ≥ 5 mm 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 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 scintigraphy (as per the 2+2 PCWG3 criteria).
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  • Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).
  • Prior progression on at least one androgen receptor pathway inhibitor (androgen receptor pathway inhibitor [ARPI], enzalutamide, abiraterone, apalutamide, darolutamide).
  • Prior treatment with only one taxane therapy in the mCRPC setting. Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting.

Who cannot join

  • History of central nervous system metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.
  • History of allergic reactions or acute hypersensitivity reactions to the components of the trial therapies and their analogs. Participants with known contraindications to high-dose corticosteroids are also excluded.
  • History of malignancy that is expected to alter life expectancy or may interfere with disease assessments. Participants with prior history of malignancy that have been adequately treated and who have been disease-free for >3 years are eligible, as are participants with adequately treated non-melanoma skin cancer or superficial bladder cancer.
  • Active autoimmune disease that has required systemic treatment (except physiologic replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on trial.
  • Known positive test for human immunodeficiency virus.
  • Presence or history of viral hepatitis infection.
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  • Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of trial treatment with the following exceptions:
  • Androgen-deprivation therapy with luteinizing hormone-releasing hormone/gonadotropin-releasing hormone (LHRH/GnRH) analogue (agonist/antagonist) is allowed.
  • ARPIs (enzalutamide, abiraterone, apalutamide, darolutamide) require a minimum washout of 2 weeks prior to the first dose of xaluritamig.
  • Prior prostate-specific membrane antigen (PSMA) radionuclide therapy cannot be given within 3 months prior to first dose of xaluritamig unless participant received <2 cycles of therapy, in which case participant cannot have received PSMA radionuclide therapy within 35 days prior to first dose.
  • Any prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
  • Any prior cluster of differentiation 3 (CD3)-directed therapy.
  • Requirement for chronic systemic corticosteroid therapy (prednisone dose >10 mg/day or equivalent) or any other immunosuppressive therapies (including anti TNFα therapies).
  • Participation on any other xaluritamig trial, regardless of whether xaluritamig was administered.

Trial locations and contacts

14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Amgen Call Center contact

866-572-6436

medinfo@amgen.com

14 sites in 2 countries

United States12 sites, 12 recruiting

  • Oncology Hematology Care Incorporated

    Cincinnati, Ohio, 45242

    Recruiting

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

    Recruiting

  • United States Oncology Regulatory Affairs Corporate Office

    Denver, Colorado, 80218

    Recruiting

  • US Oncology Research Investigational Products Center

    Denver, Colorado, 80218

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Next Oncology - Dallas

    Irving, Texas, 75039

    Recruiting

  • Sarah Cannon Research Institute Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Virginia Oncology Associates - Hampton

    Norfolk, Virginia, 23502

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • University of Pittsburgh Medical Center Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Sanford Oncology Clinic and Pharmacy

    Sioux Falls, South Dakota, 57104

    Recruiting

Other trials in United States

Australia2 sites, 2 recruiting

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050

    Recruiting

  • Monash Medical Centre

    Clayton, Victoria, 3168

    Recruiting

Other trials in Australia

About this study

Official title: A Phase 1b, Open-label Study of Xaluritamig (AMG 509) in Adults With Metastatic Castration-resistant Prostate Cancer

The primary objective of this trial is to determine the safety profile of xaluritamig at the proposed regimen in adult participants with metastatic castration-resistant prostate cancer (mCRPC).

Being tested
Xaluritamig
Keywords
Xaluritamig, AMG 509, mCRPC, Prostate Cancer
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 via short-term intravenous (IV) infusion.

Study groups in NCT07493512
Study groupRoleWhat they receive
Xaluritamig Proposed RegimenExperimentalParticipants will be dosed at the proposed regimen until disease progression or discontinuation of study treatment.
Receives: Drug: Xaluritamig

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Treatment-emergent Adverse Events

    This will include treatment-emergent adverse events, serious adverse events, treatment-related adverse events, and fatal adverse events.

    Measured: Up to 3.6 Year

Secondary outcomes (17)

  1. Maximum Plasma Concentration (Cmax) of Xaluritamig

    Measured: Up to 1 Year

  2. Time to Cmax (tmax) of Xaluritamig

    Measured: Up to 1 Year

  3. Accumulation Ratio (AR) Following Multiple Doses of Xaluritamig

    Measured: Up to 1 Year

  4. Serum Concentration Before Dosing (Ctrough) of Xaluritamig

    Measured: Up to 1 Year

  5. Area Under the Concentration-time Curve Over the Dosing Interval (AUC) of Xaluritamig

    Measured: Up to 1 Year

  6. Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Up to 3.6 Years

  7. Duration of Response (DOR) per Modified RECIST v1.1

    Measured: Up to 3.6 Years

  8. Disease Control (DC) per Modified RECIST v1.1

    Measured: Up to 3.6 Years

  9. Time to Response (TTR) per Modified RECIST v1.1

    Measured: Up to 3.6 Years

  10. Number of Participants with a Prostate-specific Antigen (PSA) 50 Response

    Measured: Up to 3.6 Years

  11. Number of Participants with a PSA 90 Response

    Measured: Up to 3.6 Years

  12. Time to PSA 50 and PSA 90 Response

    Measured: Up to 3.6 Years

  13. Duration of PSA 50 and PSA 90 Response

    Measured: Up to 3.6 Years

  14. Time to PSA Progression

    Measured: Up to 3.6 Years

  15. Time to First Subsequent Therapy

    Measured: Up to 3.6 Years

  16. Radiographic Progression-free Survival (PFS) Per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1

    Measured: Up to 3.6 Years

  17. Overall Survival (OS)

    Measured: Up to 3.6 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start28 Apr 2026
  3. Primary completion30 Jul 2030 (estimated)
  4. Study completion30 Jul 2030 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07493512
Sponsor's protocol ID
20250211
Status last verified
Sep 2026
First submitted
20 Mar 2026
Last updated
15 Sep 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Xaluritamig in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by Amgen at 14 sites in 2 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 9 inclusion and 14 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Australia. 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 3.6 Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07493512.

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 15 Sep 2026.

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