Recruiting
Phase 1

Xaluritamig

Sponsor:

Amgen

Code:

NCT07493512

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Xaluritamig

Study Details

Brief 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).

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study ID

NCT07493512

Start date

Apr 28, 2026

Status verified date

Aug, 2026

Completion date

Jul 30, 2030

Anticipated

Primary completion date

Jan 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Xaluritamig Proposed Regimen

Participants will be dosed at the proposed regimen until disease progression or discontinuation of study treatment.

Interventions

Xaluritamig

Participants will receive xaluritamig via short-term intravenous (IV) infusion.

Primary outcome measure

  • Number of Participants with Treatment-emergent Adverse Events [ Time Frame: Up to 3.6 Year ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Rocky Mountain Cancer Centers

Recruiting

Denver, Colorado, United States, 80218

United States Oncology Regulatory Affairs Corporate Office

Recruiting

Denver, Colorado, United States, 80218

US Oncology Research Investigational Products Center

Recruiting

Denver, Colorado, United States, 80218

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

University of Pittsburgh Medical Center Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Sanford Oncology Clinic and Pharmacy

Recruiting

Sioux Falls, South Dakota, United States, 57104

Sarah Cannon Research Institute Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Next Oncology - Dallas

Recruiting

Irving, Texas, United States, 75039

More Information

Sponsor

Amgen

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Xaluritamig
  • AMG 509
  • mCRPC
  • Prostate Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-07.