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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06555796




Registration number
NCT06555796
Ethics application status
Date submitted
13/08/2024
Date registered
15/08/2024

Titles & IDs
Public title
Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer
Scientific 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
Secondary ID [1] 0 0
20230238
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
High-risk Biochemical Recurrence 0 0
High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer 0 0
Non-metastatic Castration-sensitive Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Inflammatory and Immune System 0 0 0 0
Allergies
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xaluritamig

Experimental: Xaluritamig - Xaluritamig will be administered as a short-term intravenous (IV) infusion for a total of 6 cycles. One treatment cycle consists of 28 days.


Treatment: Drugs: Xaluritamig
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Number of Participants Experiencing Treatment-related Adverse Events (TRAEs)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [1] 0 0
Up to 54 months
Secondary outcome [2] 0 0
Number of Participants With a PSA 50 Response
Timepoint [2] 0 0
Up to approximately 54 months
Secondary outcome [3] 0 0
Number of Participants With a PSA 90 Response
Timepoint [3] 0 0
Up to approximately 54 months
Secondary outcome [4] 0 0
Duration of PSA 50 Response
Timepoint [4] 0 0
Up to approximately 54 months
Secondary outcome [5] 0 0
Duration of PSA 90 Response
Timepoint [5] 0 0
Up to approximately 54 months
Secondary outcome [6] 0 0
Number of Participants With Undetectable PSA
Timepoint [6] 0 0
6, 12, 24, and 36 months
Secondary outcome [7] 0 0
Time to Initiation of Androgen Deprivation Therapy or Androgen Receptor Directed Therapy
Timepoint [7] 0 0
Up to approximately 54 months
Secondary outcome [8] 0 0
Time to First use of new Anticancer Therapy
Timepoint [8] 0 0
Up to approximately 54 months
Secondary outcome [9] 0 0
Time to Metastatic Disease/Progression
Timepoint [9] 0 0
Up to approximately 54 months
Secondary outcome [10] 0 0
Time to Symptomatic Progression
Timepoint [10] 0 0
Up to approximately 54 months
Secondary outcome [11] 0 0
Time to First Symptomatic Skeletal Event
Timepoint [11] 0 0
Up to approximately 54 months
Secondary outcome [12] 0 0
Metastasis-free Survival (MFS)
Timepoint [12] 0 0
12, 24, and 36 months
Secondary outcome [13] 0 0
Number of Participants Completing Xaluritamig Monotherapy Treatment
Timepoint [13] 0 0
Up to approximately 36 months
Secondary outcome [14] 0 0
Maximum Serum Concentration (Cmax) of Xaluritamig
Timepoint [14] 0 0
Up to approximately 19 months
Secondary outcome [15] 0 0
Time to Cmax (Tmax) of Xaluritamig
Timepoint [15] 0 0
Up to approximately 19 months
Secondary outcome [16] 0 0
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig
Timepoint [16] 0 0
Up to approximately 19 months
Secondary outcome [17] 0 0
Terminal Half-life (t1/2) of Xaluritamig
Timepoint [17] 0 0
Up to approximately 19 months

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
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 [TNFa] therapies).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/03/2029
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06555796