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

Part of paid clinical trials in San Francisco, California.

Sponsor
Amgen
Study ID
NCT07140900
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xaluritamig — DRUG
    Participants will receive xaluritamig intravenously.
  • Darolutamide — DRUG
    Participants will receive darolutamide orally.
  • Abiraterone — DRUG
    Participants will receive abiraterone orally.

Study Details

The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.

Key Dates

First listed
Aug 26, 2025
Start date
Oct 7, 2025
Status verified
Jun 2026
Primary completion
Mar 27, 2028
Completion
Mar 30, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Xaluritamig with Darolutamide
    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.
  • Experimental: Xaluritamig with Abiraterone
    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.

Primary Outcome Measure

Number of Participants with Treatment-emergent Adverse Events [ Time Frame: Up to approximately 2.5 years ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94158-
Dana Farber Cancer InstituteBostonMassachusetts02215-
University of MinnesotaMinneapolisMinnesota55455-
Cleveland Clinic FoundationClevelandOhio44195-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical Center Hillman Cancer CenterPittsburghPennsylvania15232-
South Texas Accelerated Research Therapeutics - CarolinasMyrtle BeachSouth Carolina29572-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in San Francisco, CA

By research site
University of California San Francisco· San Francisco, CADana Farber Cancer Institute· Boston, MAUniversity of Minnesota· Minneapolis, MNCleveland Clinic Foundation· Cleveland, OHThomas Jefferson University· Philadelphia, PAUniversity of Pittsburgh Medical Center Hillman Cancer Center· Pittsburgh, PA

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