Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Amgen
Study ID
NCT06613100
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Xaluritamig — DRUG
    Intravenous (IV) infusion
  • GnRH Antagonist — DRUG
    Oral administration

Study Details

The primary objectives of this study are to evaluate the safety and tolerability of xaluritamig administered as monotherapy or in combination with an oral Gonadotropin-releasing Hormone (GnRH) antagonist in the neoadjuvant setting followed by radical prostatectomy, and to evaluate the feasibility and safety of a radical prostatectomy following xaluritamig administered as monotherapy or in combination with an oral GnRH antagonist in the neoadjuvant setting.

Key Dates

Start date
Nov 25, 2024
Status verified
May 2026
Primary completion
Jan 22, 2027
Completion
Jan 23, 2030

Study Design

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

Arms

  • Experimental: Cohort A - Xaluritamig
    Xaluritamig will be administered prior to radical prostatectomy.
  • Experimental: Cohort B - Xaluritamig with an Oral GnRH Antagonist
    Xaluritamig will be administered prior to radical prostatectomy. Participants will also receive an oral GnRH antagonist continuously up to the time of planned radical prostatectomy.

Primary Outcome Measure

Number of Participants who Experienced Treatment-emergent Adverse Events [ Time Frame: Up to 45 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143-
Washington UniversitySt LouisMissouri63110-
The Ohio State UniversityColumbusOhio43210-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Fred Hutchinson Cancer CenterSeattleWashington98109-1023-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California San Francisco· San Francisco, CAWashington University· St Louis, MOThe Ohio State University· Columbus, OHThomas Jefferson University· Philadelphia, PACarolina Urologic Research Center· Myrtle Beach, SCFred Hutchinson Cancer Center· Seattle, WA

Related Studies