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NCT07140900

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

StatusActive, Not Recruiting
PhasePhase 1
SponsorAmgen
Primary completion (estimated)
Track this trial

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Record History

All 10 versions: 10 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 16 words Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion moved earlier from Mar 27, 2028 to Oct 27, 2027
    • Study completion moved earlier from Mar 30, 2030 to Oct 29, 2029
    • Secondary endpoints: details revised at 2 of 10 entries
    • Site details revised at 16 of 16 sites
  2. Study sites revised (16)v9
  3. Study sites: 15 to 16v8
  4. Eligibility criteria shortened, about 7 words
    • Study sites: 14 to 15
    v7
  5. Trial sites expanded: 11 → 14 locationsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 10 to 11
    • Primary completion date: Apr 30, 2028 to Mar 27, 2028
    • Study completion date: Apr 7, 2030 to Mar 30, 2030
    v5
  2. Study sites: 4 to 10
    • Primary completion date: Mar 27, 2028 to Apr 30, 2028
    • Study completion date: Mar 30, 2030 to Apr 7, 2030
    • Secondary endpoints: details revised at 9 of 10 entries
    v4
  3. Study sites: 3 to 4v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date: Sep 29, 2025 to Oct 7, 2025
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants with Treatment-emergent Adverse Events
Timeframe: Up to approximately 2.5 years
Number of Participants with Treatment-related Adverse Events
Timeframe: Up to approximately 2.5 years
Number of Participants with Clinically Significant Changes in Vital Signs
Timeframe: Up to approximately 2.5 years
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Timeframe: Up to approximately 2.5 years

Secondary (10)

Percentage of Participants with Prostate-specific Antigen (PSA) < 0.2 ng/mL at 6 Months
Time to PSA Progression
Time to First New Systemic Anticancer Therapy
Time to Radiographic Progression per Prostate Cancer Working Group 3 (PCWG3) Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Observed Concentration at the End of a Dose Interval of Darolutamide
Show 5 moreShow less
Observed Concentration at the End of a Dose Interval of Abiraterone
Maximum Observed Serum Concentration (Cmax) of Xaluritmag
Time to Cmax (Tmax) of Xaluritmag
Area Under the Concentration Time Curve (AUC) of Xaluritmag
Half-life (t1/2) of Xaluritamig

Arms and interventions

Xaluritamig with DarolutamideExperimental

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.

Xaluritamig with AbirateroneExperimental

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.

Drugs: Xaluritamig, Darolutamide, Abiraterone

Sites

16 sites in 3 countries

United States 8, Australia 5, Switzerland 3