Clinical trial NCT06555796: Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer
Official title: A Phase 1b, Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Subjects With High-risk Biochemical Recurrence of Nonmetastatic Castration-sensitive Prostate Cancer After Definitive Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
High-risk Biochemical Recurrence
High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer
Non-metastatic Castration-sensitive Prostate Cancer
Keywords: Xaluritamig
T-Cell Engager
AMG509
STEAP1
Immunotherapy
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


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 ≥ 0.2 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, enzalutamide, apalutamide, or darolutamide for prostate cancer.
* Abiraterone acetate, enzalutamide, apalutamide, or darolutamide are allowed if administered in a neoadjuvant/adjuvant 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).

Primary outcomes:
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 2 years
measure: Number of Participants Experiencing Treatment-related Adverse Events (TRAEs)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: Up to 54 months
measure: Number of Participants With a PSA 50 Response
timeFrame: Up to approximately 54 months
measure: Number of Participants With a PSA 90 Response
timeFrame: Up to approximately 54 months
measure: Duration of PSA 50 Response
timeFrame: Up to approximately 54 months
measure: Duration of PSA 90 Response
timeFrame: Up to approximately 54 months
measure: Number of Participants With Undetectable PSA
timeFrame: 6, 12, 24, and 36 months
measure: Time to Initiation of Androgen Deprivation Therapy or Androgen Receptor Directed Therapy
timeFrame: Up to approximately 54 months
measure: Time to First use of new Anticancer Therapy
timeFrame: Up to approximately 54 months
measure: Time to Metastatic Disease/Progression
timeFrame: Up to approximately 54 months
measure: Time to Symptomatic Progression
timeFrame: Up to approximately 54 months
measure: Time to First Symptomatic Skeletal Event
timeFrame: Up to approximately 54 months
measure: Metastasis-free Survival (MFS)
timeFrame: 12, 24, and 36 months
measure: Number of Participants Completing Xaluritamig Monotherapy Treatment
timeFrame: Up to approximately 36 months
measure: Maximum Serum Concentration (Cmax) of Xaluritamig
timeFrame: Up to approximately 19 months
measure: Time to Cmax (Tmax) of Xaluritamig
timeFrame: Up to approximately 19 months
measure: Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig
timeFrame: Up to approximately 19 months
measure: Terminal Half-life (t1/2) of Xaluritamig
timeFrame: Up to approximately 19 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse
state: New South Wales
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: