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OncoMatch/Clinical Trials/NCT06613100

Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

Is NCT06613100 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Xaluritamig and GnRH Antagonist for prostate cancer.

Phase 1RecruitingAmgenNCT06613100Data as of May 2026

Treatment: Xaluritamig · GnRH Antagonist — 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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Grade: Gleason score of 4+3 or higher (Gleason)

Intermediate- or high-risk localized prostate cancer, defined as: Gleason score of 4+3 or higher AND initial PSA (iPSA) >10 OR Clinically advanced (cT3) on MRI obtained within 3 months prior to screening AND/OR Positive locoregional lymph nodes as detected by PSMA-PET scans OR ≤ 5 local lymph nodes on MRI can be enrolled.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: any treatment for prostate cancer

Exception: Participants intended for enrollment in cohort B may have received an oral GnRH antagonist up to 3 months prior to the start of screening.

Prior treatment for participant's prostate cancer. Exception: Participants intended for enrollment in cohort B may have received an oral GnRH antagonist up to 3 months prior to the start of screening.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California San Francisco · San Francisco, California
  • Washington University · St Louis, Missouri
  • The Ohio State University · Columbus, Ohio
  • Thomas Jefferson University · Philadelphia, Pennsylvania
  • Fred Hutchinson Cancer Center · Seattle, Washington

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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