Prostate CancerPhase 2NCT07737925
LuX: Xaluritamig in Participants With Metastatic Castrate Resistant Prostate Cancer and Suboptimal Response to Lutetium 177 Vipivotide Tetraxetan
A Phase 2 study testing Xaluritamig in people with Prostate Cancer and Metastatic Castrate Resistant Prostate Cancer, run by Thomas Jefferson University.
Trial summary
This is a phase 2a, open label, single arm, multi-site study of xaluritamig in mCRPC patients following treatment with ≥1 ARPI, taxane chemotherapy (if eligible) and stable or partial PSA response following 2 cycles of lutetium 177 vipivotide tetraxetan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Metastatic Castrate Resistant 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2031
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included in this study, participants should complete all screening procedures and meet all of the following criteria (i.e., evaluations performed as part of routine care prior to informed consent can be used for screening and eligibility confirmation):
- Willing and able to provide, or have a legally authorized representative provide, written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
- NOTE: Privacy authorization may be either included in the informed consent or obtained separately.
- 18 years of age and above
- Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
- Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).
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- Received ≥1 novel ARPI (e.g., enzalutamide, darolutamide, apalutamide and/or abiraterone).
- Eastern Cooperative Oncology Group (ECOG) status of 0-2 (Appendix A).
- Life expectancy of >6 months.
- Previously treated with, declined treatment with, or are considered unsuitable/unwilling for taxane regimen per investigator discretion.
- Prior completion of 2 cycles of lutetium 177 vipivotide tetraxetan between 16 and 6 weeks prior to initiation of study treatment, with evidence of PSA response between 0-90% decrease from the pre- lutetium 177 vipivotide tetraxetan baseline, documented by a PSA measurement obtained within 4 weeks of second dose of lutetium 177 vipivotide tetraxetan.
- Participants must have either:
- baseline measurable disease per RECIST v1.1 at time of screening or
- baseline PSA ≥ 2 ng/mL at time of screening.
- Patients must have adequate organ function:
- Bone marrow reserve: i. White blood cell (WBC) count ≥2.5 x 10⁹ /L OR absolute neutrophil count (ANC) ≥1.5 x 10⁹/L ii. Platelets ≥75 x 10⁹ /L iii. Hemoglobin ≥9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L) b. Hepatic: iv. AST and ALT ≤ 3 X upper limit of normal (ULN) (or ≤ 5 X ULN for participants with liver involvement) v. total bilirubin (TBL) ≤ 1.5 X ULN (or ≤ 2 X ULN for participants with liver involvement). For patients with known Gilbert's Syndrome, < 3 X ULN is permitted.
- Renal: estimated glomerular filtration rate based on MDRD (Modification of Diet in Renal Disease) calculation ≥ 30 ml/min/1.73 m2.
- Pulmonary Function: Baseline oxygen saturation > 92% on room air at rest and no oxygen supplementation.
- Cardiac function: Left ventricular ejection fraction > 50% (screening echocardiography only required in subjects with known history of cardiac disease, prior MI, angina pectoris, coronary artery bypass graft (CABG), angioplasty, stent placement).
- Participants with partners of childbearing potential must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study including 6 months after the last dose of study drug. Sperm donation is prohibited during the study and for 6 months after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
Who cannot join
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments in the judgment of the site Principal Investigator (PI). Participants with prior history of malignancy that have been adequately treated and who have been disease-free for > 3 years are eligible, as are subjects with adequately treated non-melanoma skin cancer or superficial bladder cancer.
- Requirement for chronic systemic corticosteroid therapy (prednisone dose >10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-TNFα therapies) unless stopped (with adequate tapering) within 7 days prior to dosing. Corticosteroid treatment for adverse event management as described in Section 6.1.10 is allowed.
- Previous PSMA-targeted radioligand therapy, aside from treatment with 2 cycles of lutetium 177 vipivotide tetraxetan, is not allowed.
- Prior PSMA radioligand therapy within 6 weeks of first dose of study treatment.
- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, or investigational therapy.
- Untreated central nervous system metastases or leptomeningeal disease, symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
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- Active systemic infection treated with IV antibiotics within 7 days prior to the first dose of study drugs.
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are permitted.
- History or evidence of inflammatory bowel disease (ulcerative colitis or Chron disease) or any other gastrointestinal disorder causing chronic nausea, vomiting or diarrhea (CTCAE ≥ grade 2).
- Evidence of interstitial lung disease or active, non-infectious pneumonitis, or uncontrolled asthma.
- Recent history of arterial (e.g. stroke or transient ischemic attack) or venous (e.g., pulmonary embolism or deep vein thrombosis) thrombosis; within 12 and 6 months prior to first dose of study treatment, respectively.
- Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as determined by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT interval by Fredericia prolongation > 480 ms, electrolyte disturbances, etc), or patients with congenital long QT syndrome.
- Recent history of myocardial infarction and/or symptomatic congestive hear failure (New York Heart Association ≥ class II) within 12 months of first dose of study treatment, with the exception of ischemia or non ST segment elevation myocardial infarction controlled with stent placement and confirmed by a cardiologist more than 6 months prior to first dose of study treatment.
- Unresolved toxicities from prior anti-tumor therapy not having resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 or less, with the exception of alopecia, neuropathy, endocrinopathy, xerostomia, or toxicities that are stable and well-controlled.
- Known allergy to any of the compounds under investigation.
- Any other condition which, in the opinion of the investigator, would preclude participation in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: LuX: A Feasibility Study of Xaluritamig in Participants With Metastatic Castrate Resistant Prostate Cancer and Suboptimal Response to Lutetium 177 Vipivotide Tetraxetan
This is a phase 2a, open label, single arm, multi-site study of xaluritamig in mCRPC patients following treatment with ≥1 ARPI, taxane chemotherapy (if eligible) and stable or partial PSA response following 2 cycles of lutetium 177 vipivotide tetraxetan.
Participants will continue treatment until clinical or radiographic progression of disease, withdrawal, or toxicity requiring discontinuation of therapy. All participants will be evaluated for overall response per RECIST v1.1,8 radiographic progression free survival (rPFS) by Prostate Cancer Working Group 3 (PCWG3) criteria, and PSA response. Approximately 30 participants will be enrolled. There is no data on response with alternative treatments following lutetium 177 vipivotide tetraxetan against which to benchmark the response rate. This phase 2a study will serve as an exploratory pilot to determine if a larger phase 2b study is warranted in this setting.
Read the detailed description
Primary Objective and Endpoints
To evaluate the efficacy of xaluritamig following lutetium 177 vipivotide tetraxetan in patients with mCRPC, using a composite endpoint defined as the proportion of participants who achieve either of the following:
- Partial or complete response up to 24 weeks by local investigator's assessment per RECIST v1.1 in participants with baseline measurable disease, with confirmation at least 4 weeks after the initial observation; OR
- PSA90, defined as a decline of ≥ 90% from baseline PSA (for participants with a baseline PSA ≥ 2.0 ng/mL) up to 24 weeks, confirmed by a subsequent PSA value obtained ≥3 weeks later.
Secondary Objectives and Endpoints
To evaluate the safety and efficacy of xaluritamig following lutetium 177 vipivotide tetraxetan in patients with mCRPC as measured by:
- Radiographic PFS
- Duration of response, per RECIST v1.1
- Time to PSA response (30%, 50%, 70%, and 90%)
- Time to PSA progression
- Changes in laboratory safety evaluations (complete blood count [CBC], comprehensive metabolic panel [CMP], lactate dehydrogenase [LDH])
- Treatment-emergent adverse events (TEAE) following treatment initiation.
- Duration of PSA 50/90 response
Correlative/Exploratory/Tertiary Objectives The following tertiary objectives are included in this protocol for exploratory purposes. However, it is important to note that these objectives may not be pursued depending on resource availability, feasibility, or other considerations during the course of the trial.
- To perform quantitative analysis of peripheral immune profile and cytokine profiles.
- To perform somatic genomic analysis and measure circulating tumor cells.
- To conduct immune and molecular analyses and exploratory prostate cancer biomarker studies to associate with clinical outcomes.
- Being tested
- Xaluritamig
- Keywords
- Xaluritamig, AMG509, Lutetium 177 Vipivotide Tetraxetan, Sequential Targeting, PSMA, STEAP1, T-cell engager, mCRPC
- 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
short-term IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Xaluritamig | Experimental | Participants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion. Receives: Drug: Xaluritamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants who achieve Partial or Complete Response or PSA90
Proportion of participants with mCRPC treated with xaluritamig after lutetium-177 vipivotide tetraxetan who achieve either: (1) a confirmed Complete Response (CR) or Partial Response (PR) within 24 weeks by local investigator assessment per RECIST v1.1 in participants with baseline measurable disease, with confirmation ≥4 weeks after initial response; or (2) a confirmed PSA90 response, defined as a ≥90% decline from baseline PSA in participants with baseline PSA ≥2.0 ng/mL within 24 weeks, confirmed by a subsequent PSA assessment obtained ≥2 weeks later. RECIST v1.1 classifies tumor response as CR (disappearance of all target lesions), PR (≥30% decrease in tumor size), Stable Disease (SD), or Progressive Disease (PD; ≥20% increase in tumor size or new lesions). Higher response rates indicate greater treatment efficacy.
Measured: Baseline to 24 weeks
Secondary outcomes (6)
Radiographic Progression-Free Survival (rPFS)
Time from initiation of study treatment to the earliest occurrence of radiographic disease progression per RECIST v1.1 or death from any cause, whichever occurs first. rPFS will be summarized as median time-to-event with a 90% confidence interval using the Kaplan-Meier method. Progression is determined using RECIST v1.1 and PCWG3 guidelines. New lesions require confirmation on a subsequent scan, with at least two initially identified new lesions remaining present. PCWG3 assesses progression in metastatic castration-resistant prostate cancer using RECIST v1.1 for soft tissue disease, bone scan criteria (including the "2+2" rule for new lesions), and PSA changes. RECIST v1.1 classifies response as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). Longer rPFS indicates better disease control; shorter rPFS indicates faster progression or treatment failure.
Measured: Up to 2 years post-treatment
Duration of response (DOR)
Duration of response will be evaluated for participants and is defined as the time from the first evidence of CR/PR per the Investigator to the first evidence of disease progression (assessed in soft tissue per RECIST v1.1), or death, whichever occurs first. Will be reported as median time-to-event and 90% confidence interval according to the Kaplan Meier product-limit method.
RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) is a system for evaluating tumor response to treatment using four categories: Complete Response (CR) for disappearance of all target lesions, Partial Response (PR) for at least a 30% decrease in tumor size, Stable Disease (SD) for no significant change, and Progressive Disease (PD) for at least a 20% increase or new lesions. Minimum measurable size is 10 mm for solid tumors and 15 mm for lymph nodes. Better outcomes correspond to CR or PR, while PD indicates worsening.
Measured: From Baseline measurable disease until the first date that progressive disease is objectively documented, assesed up to 58 months.
Time to Prostate-Specific Antigen (PSA) response (30%, 50%, 70%, and 90%)
Defined as time to PSA decline of ≥ 30%, 50%, 70%, and 90% from start of study treatment. Median time to a decrease in PSA of 30%, 50%, 70%, and 90% from treatment initiation confirmed by a subsequent PSA value obtained ≥3 weeks later. Will be reported as median time-to-event and 90% confidence interval according to the Kaplan Meier product-limit method.
Measured: assessed up to 58 months
Time to Prostate-Specific Antigen (PSA) Progression
Time from treatment initiation to the date of first PSA value demonstrating progression confirmed by a subsequent PSA value obtained ≥3 weeks later. Will be reported as median time-to-event and 90% confidence interval according to the Kaplan Meier product-limit method.
Measured: From start of study treatment until documented PSA progression, assessed up to 58 months
Duration of PSA 50/90 response
Duration of PSA 50/90 response, defined as the time from the first documented PSA 50/90 response to PSA progression by PCWG3 or death
Measured: assessed up to 58 months
Number of Treatment-Emergent Adverse Events (TEAE) following treatment initiation
TEAEs, SAEs, AEs resulting in treatment withdrawal from start of study treatment to the end of safety follow-up will be summarized (number and percentage of participants) from date of treatment initiation until AEs resolve to ≤ Grade 1 or baseline, are deemed clinically insignificant, and/or until a new anti-prostate cancer therapy starts, whichever occurs first.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionOct 2031 (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 Thomas Jefferson UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Clinical Trials Consortium, Amgen
- Responsible party
- Sponsor
- Investigators
- Kevin K Zarrabi, MD, MS, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737925
- Sponsor's protocol ID
- iRISID-2025-1294
- Other IDs
- JT 47440
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LuX: A Feasibility Study of Xaluritamig in Participants With Metastatic Castrate Resistant Prostate Cancer and Suboptimal Response to Lutetium 177 Vipivotide Tetraxetan
- ClinicalTrials.gov ID
- NCT07737925
- Acronym / sponsor ID
- iRISID-2025-1294
- Keywords
- Xaluritamig, AMG509, Lutetium 177 Vipivotide Tetraxetan, Sequential Targeting, PSMA, STEAP1, T-cell engager, mCRPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Prostate Cancer Clinical Trials Consortium, Amgen
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 30 Jul 2026 (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.
This is a phase 2a, open label, single arm, multi-site study of xaluritamig in mCRPC patients following treatment with ≥1 ARPI, taxane chemotherapy (if eligible) and stable or partial PSA response following 2 cycles of lutetium 177 vipivotide tetraxetan.
Participants will continue treatment until clinical or radiographic progression of disease, withdrawal, or toxicity requiring discontinuation of therapy. All participants will be evaluated for overall response per RECIST v1.1,8 radiographic progression free survival (rPFS) by Prostate Cancer Working Group 3 (PCWG3) criteria, and PSA response. Approximately 30 participants will be enrolled. There is no data on response with alternative treatments following lutetium 177 vipivotide tetraxetan against which to benchmark the response rate. This phase 2a study will serve as an exploratory pilot to determine if a larger phase 2b study is warranted in this setting.
Detailed description
Primary Objective and Endpoints
To evaluate the efficacy of xaluritamig following lutetium 177 vipivotide tetraxetan in patients with mCRPC, using a composite endpoint defined as the proportion of participants who achieve either of the following:
- Partial or complete response up to 24 weeks by local investigator's assessment per RECIST v1.1 in participants with baseline measurable disease, with confirmation at least 4 weeks after the initial observation; OR
- PSA90, defined as a decline of ≥ 90% from baseline PSA (for participants with a baseline PSA ≥ 2.0 ng/mL) up to 24 weeks, confirmed by a subsequent PSA value obtained ≥3 weeks later.
Secondary Objectives and Endpoints
To evaluate the safety and efficacy of xaluritamig following lutetium 177 vipivotide tetraxetan in patients with mCRPC as measured by:
- Radiographic PFS
- Duration of response, per RECIST v1.1
- Time to PSA response (30%, 50%, 70%, and 90%)
- Time to PSA progression
- Changes in laboratory safety evaluations (complete blood count [CBC], comprehensive metabolic panel [CMP], lactate dehydrogenase [LDH])
- Treatment-emergent adverse events (TEAE) following treatment initiation.
- Duration of PSA 50/90 response
Correlative/Exploratory/Tertiary Objectives The following tertiary objectives are included in this protocol for exploratory purposes. However, it is important to note that these objectives may not be pursued depending on resource availability, feasibility, or other considerations during the course of the trial.
- To perform quantitative analysis of peripheral immune profile and cytokine profiles.
- To perform somatic genomic analysis and measure circulating tumor cells.
- To conduct immune and molecular analyses and exploratory prostate cancer biomarker studies to associate with clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Xaluritamig | Experimental | Drug: XaluritamigParticipants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- To be included in this study, participants should complete all screening procedures and meet all of the following criteria (i.e., evaluations performed as part of routine care prior to informed consent can be used for screening and eligibility confirmation):
- Willing and able to provide, or have a legally authorized representative provide, written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
- NOTE: Privacy authorization may be either included in the informed consent or obtained separately.
- 18 years of age and above
- Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
Key exclusion criteria (16 listed)
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments in the judgment of the site Principal Investigator (PI). Participants with prior history of malignancy that have been adequately treated and who have been disease-free for > 3 years are eligible, as are subjects with adequately treated non-melanoma skin cancer or superficial bladder cancer.
- Requirement for chronic systemic corticosteroid therapy (prednisone dose >10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-TNFα therapies) unless stopped (with adequate tapering) within 7 days prior to dosing. Corticosteroid treatment for adverse event management as described in Section 6.1.10 is allowed.
- Previous PSMA-targeted radioligand therapy, aside from treatment with 2 cycles of lutetium 177 vipivotide tetraxetan, is not allowed.
- Prior PSMA radioligand therapy within 6 weeks of first dose of study treatment.
- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, or investigational therapy.
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 |
|---|---|---|
| Xaluritamigshort-term IV infusion | Drug | Arm 1: Xaluritamig |
Primary outcome
Proportion of Participants who achieve Partial or Complete Response or PSA90
Time frame: Baseline to 24 weeks
Proportion of participants with mCRPC treated with xaluritamig after lutetium-177 vipivotide tetraxetan who achieve either: (1) a confirmed Complete Response (CR) or Partial Response (PR) within 24 weeks by local investigator assessment per RECIST v1.1 in participants with baseline measurable disease, with confirmation ≥4 weeks after initial response; or (2) a confirmed PSA90 response, defined as a ≥90% decline from baseline PSA in participants with baseline PSA ≥2.0 ng/mL within 24 weeks, confirmed by a subsequent PSA assessment obtained ≥2 weeks later. RECIST v1.1 classifies tumor response as CR (disappearance of all target lesions), PR (≥30% decrease in tumor size), Stable Disease (SD), or Progressive Disease (PD; ≥20% increase in tumor size or new lesions). Higher response rates indicate greater treatment efficacy.
6 secondary outcomes
Radiographic Progression-Free Survival (rPFS)
Time frame: Up to 2 years post-treatment
Duration of response (DOR)
Time frame: From Baseline measurable disease until the first date that progressive disease is objectively documented, assesed up to 58 months.
Time to Prostate-Specific Antigen (PSA) response (30%, 50%, 70%, and 90%)
Time frame: assessed up to 58 months
Time to Prostate-Specific Antigen (PSA) Progression
Time frame: From start of study treatment until documented PSA progression, assessed up to 58 months
Duration of PSA 50/90 response
Time frame: assessed up to 58 months
Number of Treatment-Emergent Adverse Events (TEAE) following treatment initiation
Time frame: Up to 3 years
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 14 Aug 2026.
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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.
Kevin K Zarrabi, MD, MS principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xaluritamig in people with Prostate Cancer and Metastatic Castrate Resistant Prostate Cancer, run by Thomas Jefferson University.
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 20 inclusion and 16 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: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Site Public Contact (215-600-9151, ONCTrialNow@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants who achieve Partial or Complete Response or PSA90 (time frame: Baseline to 24 weeks). 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 14 Aug 2026.