Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

Amgen

Status and phase: Enrolling; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: GnRH Antagonist; Drug: Xaluritamig

Study type: Interventional

Funder types: Industry

Identifiers

NCT06613100

2024-511965-13 (Other Identifier)

20230237

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants are eligible to be included in the study only if all the following criteria apply:

• Participants planned to undergo radical prostatectomy.

• Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. 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 Magnetic Resonance Imaging (MRI) obtained within 3 months prior to screening AND/OR
  • Positive locoregional lymph nodes as detected by prostate-specific membrane antigen-positron emission tomography (PSMA-PET) scans OR ≤ 5 local lymph nodes on MRI can be enrolled.

• Participants must have undergone a PSMA-PET (CT or MRI) scan within 3 months prior to screening as part of the standard of care (SOC).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• 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.

• Any evidence of metastases outside of the surgical resection field identified by conventional imaging or PSMA-PET scans.

• Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.

• Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment:

  - Participant has known active infection requiring antibiotic treatment. Upon completion of antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.

• Recent history of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis) within 6 and 3 months prior to the first dose of study treatment, respectively. Note: Participants with a history of venous thrombosis must be on stable anti-coagulation.

• Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association ≥ class II) within 12 months of first dose of xaluritamig with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement more than 6 months prior to first dose of xaluritamig.

• Requirement for chronic systemic corticosteroid therapy unless stopped (with adequate tapering) within 7 days prior to dosing.

• Currently receiving treatment in another investigational device or drug study, or less than 4 weeks (since ending treatment on another investigational device or drug study[ies]). Other investigational procedures and participation in observational research studies while participating in this study are excluded with the exception of investigational scans.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cohort A - Xaluritamig

Experimental group

Description:

Xaluritamig will be administered prior to radical prostatectomy.

Treatment:

Drug: Xaluritamig

Cohort B - Xaluritamig with an Oral GnRH Antagonist

Experimental group

Description:

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.

Treatment:

Drug: Xaluritamig

Drug: GnRH Antagonist