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OncoMatch/Clinical Trials/NCT06613100

Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

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

Phase 1RecruitingAmgenNCT06613100Data as of Jun 2026Location: United States · Germany

Treatment: Xaluritamig · GnRH AntagonistThe 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

Treatments studied

Other

XaluritamigGnRH Antagonist

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)

Demographics

Male only

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 →

Frequently asked questions

Is NCT06613100 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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