Prostate CancerPhase 1NCT06613100
Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
A Phase 1 study testing Xaluritamig and GnRH Antagonist in people with Prostate Cancer, run by Amgen at 9 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Xaluritamig and GnRH Antagonist
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 25 Nov 2024to 4 Mar 2030
- 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
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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 locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Recruiting
University of California San Francisco
San Francisco, California, 94143
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109-1023
- Recruiting
Washington University
St Louis, Missouri, 63110
Germany2 sites, 2 recruiting
- Recruiting
Universitaetsklinikum Essen
Essen, 45147
- Recruiting
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246
About this study
Official title: A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, and Feasibility of Neoadjuvant Xaluritamig Therapy Prior to Radical Prostatectomy in Subjects With Newly Diagnosed Localized Intermediate or High-Risk Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- Xaluritamig, GnRH Antagonist
- Keywords
- Xaluritamig, AMG509, Localized Prostate Cancer, Prostate Cancer, Neoadjuvant Therapy, Immunotherapy, T-Cell Engager, STEAP1
- 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
Intravenous (IV) infusion
GnRH AntagonistDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Xaluritamig | Experimental | Xaluritamig will be administered prior to radical prostatectomy. Receives: Drug: Xaluritamig |
| Cohort B - Xaluritamig with an Oral GnRH Antagonist | Experimental | 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. Receives: Drug: Xaluritamig; Drug: GnRH Antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experienced Treatment-emergent Adverse Events
Inclusive of adverse events, serious adverse events, and changes in vital signs and clinical laboratory tests.
Measured: Up to 45 months
Number of Participants who Experienced Treatment-related Adverse Events
Measured: Up to 28 months
Number of Participants who Received Radical Prostatectomy After Completing Xaluritamig Treatment
Measured: Up to 25 months
Number of Participants who Experienced Complications of Radical Prostatectomy According to Clavien-Dindo Classification
Measured: Up to 28 months
Secondary outcomes (13)
Change in Prostate-specific Antigen (PSA) Levels from Baseline to End of Xaluritamig Treatment
Measured: Up to 25 months
Prostate Imaging-Reporting and Data System (PI-RADS) Score
Measured: Up to 25 months
Pathological Complete Response (pCR) Following Radical Prostatectomy
Measured: Up to 25 months
Minimal Residual Disease (MRD)
Measured: Up to 25 months
Number of Participants who Rise to PSA ≥ 0.2 ng/mL Post-radical Prostatectomy
Measured: Up to 45 months
Time to PSA Rise ≥ 0.2 ng/mL Post-radical Prostatectomy
Measured: Up to 45 months
Undetectable PSA at SFU
Measured: Up to 26 months
PSA Progression-free Survival
Measured: Up to 45 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Measured: Up to 45 months
Time to Maximum Concentration (Tmax) of Xaluritamig
Measured: Up to 45 months
Area Under the Concentration Time Curve (AUC) Over the Dosing Interval
Measured: Up to 45 months
Accumulation Following Multiple Dosing
Measured: Up to 45 months
Half-life (t1/2) of Xaluritamig
Measured: Up to 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start25 Nov 2024
- Primary completion17 Feb 2027 (estimated)
- Study completion4 Mar 2030 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- NCT06613100
- Sponsor's protocol ID
- 20230237
- Other IDs
- 2024-511965-13
- Status last verified
- Jul 2026
- First submitted
- 23 Sep 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Jul 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 Feasibility of Neoadjuvant Xaluritamig Therapy Prior to Radical Prostatectomy in Subjects With Newly Diagnosed Localized Intermediate or High-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT06613100
- Acronym / sponsor ID
- 20230237
- Conditions
- Prostate Cancer
- Keywords
- Xaluritamig, AMG509, Localized Prostate Cancer, Prostate Cancer, Neoadjuvant Therapy, Immunotherapy, T-Cell Engager, STEAP1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 17 Feb 2027 (estimated)
- Study completion
- 4 Mar 2030 (estimated)
- First posted
- 25 Sep 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Xaluritamig | Experimental | Drug: XaluritamigXaluritamig will be administered prior to radical prostatectomy. |
| Cohort B - Xaluritamig with an Oral GnRH Antagonist | Experimental | Drug: Xaluritamig, Drug: GnRH AntagonistXaluritamig will be administered prior to radical prostatectomy. Participants will also receive an oral GnRH antagonist continuously up to the time of planned radical prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- Prior treatment for participant's prostate cancer.
- 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:
- 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.
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 509Intravenous (IV) infusion | Drug | Cohort A - Xaluritamig, Cohort B - Xaluritamig with an Oral GnRH Antagonist |
| GnRH AntagonistOral administration | Drug | Cohort B - Xaluritamig with an Oral GnRH Antagonist |
Primary outcome
Number of Participants who Experienced Treatment-emergent Adverse Events
Time frame: Up to 45 months
Inclusive of adverse events, serious adverse events, and changes in vital signs and clinical laboratory tests.
Number of Participants who Experienced Treatment-related Adverse Events
Time frame: Up to 28 months
Number of Participants who Received Radical Prostatectomy After Completing Xaluritamig Treatment
Time frame: Up to 25 months
Number of Participants who Experienced Complications of Radical Prostatectomy According to Clavien-Dindo Classification
Time frame: Up to 28 months
13 secondary outcomes
Change in Prostate-specific Antigen (PSA) Levels from Baseline to End of Xaluritamig Treatment
Time frame: Up to 25 months
Prostate Imaging-Reporting and Data System (PI-RADS) Score
Time frame: Up to 25 months
Pathological Complete Response (pCR) Following Radical Prostatectomy
Time frame: Up to 25 months
Minimal Residual Disease (MRD)
Time frame: Up to 25 months
Number of Participants who Rise to PSA ≥ 0.2 ng/mL Post-radical Prostatectomy
Time frame: Up to 45 months
Time to PSA Rise ≥ 0.2 ng/mL Post-radical Prostatectomy
Time frame: Up to 45 months
Undetectable PSA at SFU
Time frame: Up to 26 months
PSA Progression-free Survival
Time frame: Up to 45 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Time frame: Up to 45 months
Time to Maximum Concentration (Tmax) of Xaluritamig
Time frame: Up to 45 months
Area Under the Concentration Time Curve (AUC) Over the Dosing Interval
Time frame: Up to 45 months
Accumulation Following Multiple Dosing
Time frame: Up to 45 months
Half-life (t1/2) of Xaluritamig
Time frame: Up to 45 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 31 Jul 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.
MD study director
Amgen
9 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 and GnRH Antagonist in people with Prostate Cancer, run by Amgen at 9 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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Germany. 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?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experienced Treatment-emergent Adverse Events (time frame: Up to 45 months). The study lists 4 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 31 Jul 2026.