Prostate CancerPhase 1NCT06555796
Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer
A Phase 1 study testing Xaluritamig in people with Prostate Cancer and High-risk Biochemical Recurrence, run by Amgen at 11 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, High-risk Biochemical Recurrence, High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer
- What is being tested?
- Xaluritamig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 23 Sep 2024to 7 May 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan during or within 3 months of screening.
Who cannot join
- Present evidence of metastatic disease in conventional CT scan and/or bone scan
- Participants that present PSMA-positive lesions in the PSMA 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.
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- 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.
- Autoimmune disease requiring systemic immunosuppression within the past 2 years.
- 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) unless stopped (with adequate tapering) within 7 days prior to dosing.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States8 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Oregon Health and Science University
Portland, Oregon, 97239
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Australia3 sites
Chris OBrien Lifehouse
Camperdown, New South Wales, 2050
Cabrini Hospital
Malvern, Victoria, 3144
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
About this study
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
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).
- Conditions
- Prostate Cancer, High-risk Biochemical Recurrence, High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer, Non-metastatic Castration-sensitive Prostate Cancer
- Being tested
- Xaluritamig
- Keywords
- Xaluritamig, T-Cell Engager, AMG509, STEAP1, Immunotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XaluritamigDrug
Also called AMG 509
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Xaluritamig | Experimental | Xaluritamig will be administered as a short-term intravenous (IV) infusion for a total of 6 cycles. One treatment cycle consists of 28 days for cycles 1-2 and 56 days for cycles 3-6. Receives: Drug: Xaluritamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Events categorized as adverse events (AEs) starting on or after first dose of investigational product (xaluritamig) as determined by the flag indicating if the AE started prior to the first dose on the Events Electronic Case Report Form (eCRF) and including 30 days after the last dose of investigational product (xaluritamig) or end of study date, whichever is earlier.
Measured: Up to approximately 2 years
Number of Participants Experiencing Treatment-related Adverse Events (TRAEs)
A TRAE is any TEAE that per investigators' review has a reasonable possibility of being caused by the investigational product (xaluritamig) determined by the flag indicating an event may have been caused by the investigational product (xaluritamig) on the Events eCRF. In the unlikely event that the flag is missing, the TEAE will be considered related.
Measured: Up to approximately 2 years
Secondary outcomes (15)
Time to Prostate-specific Antigen (PSA) Progression
Measured: Up to 50 months
Number of Participants With a PSA 50 Response
Measured: Up to approximately 50 months
Number of Participants With a PSA 90 Response
Measured: Up to approximately 50 months
Duration of PSA 50 Response
Measured: Up to approximately 50 months
Duration of PSA 90 Response
Measured: Up to approximately 50 months
Number of Participants With Undetectable PSA
Measured: Up to approximately 50 months
Time to Initiation of Androgen Deprivation Therapy or Androgen Receptor Directed Therapy
Measured: Up to approximately 50 months
Time to First use of new Anticancer Therapy
Measured: Up to approximately 50 months
Time to Metastatic Disease/Progression
Measured: Up to approximately 50 months
Metastasis-free Survival (MFS)
Measured: Up to approximately 50 months
Number of Participants Completing Xaluritamig Monotherapy Treatment
Measured: Up to approximately 24 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Measured: Up to approximately 24 months
Time to Cmax (Tmax) of Xaluritamig
Measured: Up to approximately 24 months
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig
Measured: Up to approximately 24 months
Terminal Half-life (t1/2) of Xaluritamig
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start23 Sep 2024
- Primary completion13 Mar 2027 (estimated)
- Study completion7 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555796
- Sponsor's protocol ID
- 20230238
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06555796
- Acronym / sponsor ID
- 20230238
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 13 Mar 2027 (estimated)
- Study completion
- 7 May 2029 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xaluritamig | Experimental | Drug: XaluritamigXaluritamig will be administered as a short-term intravenous (IV) infusion for a total of 6 cycles. One treatment cycle consists of 28 days for cycles 1-2 and 56 days for cycles 3-6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- Present evidence of metastatic disease in conventional CT scan and/or bone scan
- Participants that present PSMA-positive lesions in the PSMA PET scan may be enrolled if the conventional imaging does not show suspicion of metastatic disease.
- Prior hormonal therapy, exceptions include:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XaluritamigAlso: AMG 509IV infusion | Drug | Xaluritamig |
Primary outcome
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2 years
Events categorized as adverse events (AEs) starting on or after first dose of investigational product (xaluritamig) as determined by the flag indicating if the AE started prior to the first dose on the Events Electronic Case Report Form (eCRF) and including 30 days after the last dose of investigational product (xaluritamig) or end of study date, whichever is earlier.
Number of Participants Experiencing Treatment-related Adverse Events (TRAEs)
Time frame: Up to approximately 2 years
A TRAE is any TEAE that per investigators' review has a reasonable possibility of being caused by the investigational product (xaluritamig) determined by the flag indicating an event may have been caused by the investigational product (xaluritamig) on the Events eCRF. In the unlikely event that the flag is missing, the TEAE will be considered related.
15 secondary outcomes
Time to Prostate-specific Antigen (PSA) Progression
Time frame: Up to 50 months
Number of Participants With a PSA 50 Response
Time frame: Up to approximately 50 months
Number of Participants With a PSA 90 Response
Time frame: Up to approximately 50 months
Duration of PSA 50 Response
Time frame: Up to approximately 50 months
Duration of PSA 90 Response
Time frame: Up to approximately 50 months
Number of Participants With Undetectable PSA
Time frame: Up to approximately 50 months
Time to Initiation of Androgen Deprivation Therapy or Androgen Receptor Directed Therapy
Time frame: Up to approximately 50 months
Time to First use of new Anticancer Therapy
Time frame: Up to approximately 50 months
Time to Metastatic Disease/Progression
Time frame: Up to approximately 50 months
Metastasis-free Survival (MFS)
Time frame: Up to approximately 50 months
Number of Participants Completing Xaluritamig Monotherapy Treatment
Time frame: Up to approximately 24 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Time frame: Up to approximately 24 months
Time to Cmax (Tmax) of Xaluritamig
Time frame: Up to approximately 24 months
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig
Time frame: Up to approximately 24 months
Terminal Half-life (t1/2) of Xaluritamig
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xaluritamig in people with Prostate Cancer and High-risk Biochemical Recurrence, run by Amgen at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.