Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer

Trial Title: Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer

NCT ID: NCT06555796

Condition: Prostate Cancer
High-risk Biochemical Recurrence
High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer
Non-metastatic Castration-sensitive Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Recurrence

Conditions: Keywords:
Xaluritamig
T-Cell Engager
AMG509
STEAP1
Immunotherapy

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Xaluritamig
Description: IV infusion
Arm group label: Xaluritamig

Other name: AMG 509

Summary: The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).

Criteria for eligibility:
Criteria:
Inclusion Criteria - Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. - Prostate cancer initially treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both (eg, salvage radiotherapy), with curative intent. - PSA doubling time ≤ 12 months. - Participants must have biochemically recurrent disease after definitive treatment to prostate by either RP or XRT. - Screening PSA by the local laboratory ≥ 1 ng/mL for participants who had RP (with or without XRT) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir (local assessments) for participants who had XRT or brachytherapy only as primary treatment for prostate cancer. - Serum testosterone ≥ 150 ng/dL (5.2 nmol/L). - Participants must have undergone a 68Ga-PSMA-11 or a piflufolastat F18 PET scan during or within 3 months of screening. Exclusion Criteria - Present evidence of metastatic disease in conventional CT scan and/or bone scan - Participants that present prostate-specific membrane antigen (PSMA)-positive lesions in the 68Ga-PSMA-11 or the piflufolastat F18 positron emission tomography (PET) scan may be enrolled if the conventional imaging does not show suspicion of metastatic disease. - Prior hormonal therapy, exceptions include: - Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before enrollment, or - A single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before enrollment. - Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer. - Abiraterone acetate or enzalutamide are allowed if administered in a neoadjuvant setting ≤ 36 months in duration and ≥ 9 months before enrollment. - Prior systemic biologic therapy, including immunotherapy, for prostate cancer. - If, in the investigator's opinion, salvage therapy is the preferred intervention. - Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. - Participant 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. - Requirement for chronic systemic corticosteroid therapy (prednisone dose > 10 mg/day or equivalent) or any other immunosuppressive therapies (including anti tumor necrosis factor alpha [TNFα] therapies).

Gender: Male

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Minnesota Medical Center Fairview

Address:
City: Minneapolis
Zip: 55455
Country: United States

Status: Recruiting

Facility:
Name: Cabrini Hospital

Address:
City: Malvern
Zip: 3144
Country: Australia

Status: Recruiting

Facility:
Name: Peter MacCallum Cancer Centre

Address:
City: Melbourne
Zip: 3000
Country: Australia

Status: Recruiting

Start date: September 23, 2024

Completion date: March 23, 2029

Lead sponsor:
Agency: Amgen
Agency class: Industry

Source: Amgen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06555796
http://www.amgentrials.com