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New treatment option for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official title Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07493512
What this study is testing
What is Xaluritamig?
Xaluritamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic castration-resistant prostate cancer (mcrpc).
Also referred to as AMG 509.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this trial is to determine the safety profile of xaluritamig at the proposed regimen in adult participants with metastatic castration-resistant prostate cancer (mCRPC).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with...
- mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scintigraphy imaging...
- Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
- Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start...
- Soft tissue progression defined as an increase ≥ 20% and an absolute increase of ≥ 5 mm in the sum of the diameter (SOD) (short axis for nodal...
You likely can't join if
- History of central nervous system metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.
- History of allergic reactions or acute hypersensitivity reactions to the components of the trial therapies and their analogs. Participants with known...
- History of malignancy that is expected to alter life expectancy or may interfere with disease assessments. Participants with prior history of...
- Active autoimmune disease that has required systemic treatment (except physiologic replacement therapy) within the past 2 years or any other diseases...
- Known positive test for human immunodeficiency virus.
- Presence or history of viral hepatitis infection.
See the full eligibility criteria
- Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
- mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scintigraphy imaging obtained within 28 days prior to enrollment.
- Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
- Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
- Soft tissue progression defined as an increase ≥ 20% and an absolute increase of ≥ 5 mm in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on...
- Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scintigraphy (as per the 2+2 PCWG3 criteria).
- Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL or \<1.7 nmol/L).
- Prior progression on at least one androgen receptor pathway inhibitor (androgen receptor pathway inhibitor [ARPI], enzalutamide, abiraterone, apalutamide, darolutamide).
- Prior treatment with only one taxane therapy in the mCRPC setting. Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also...
- History of central nervous system metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.
- History of allergic reactions or acute hypersensitivity reactions to the components of the trial therapies and their analogs. Participants with known contraindications to high-dose corticosteroids are also excluded.
- History of malignancy that is expected to alter life expectancy or may interfere with disease assessments. Participants with prior history of malignancy that have been adequately treated and who have been disease-free...
- Active autoimmune disease that has required systemic treatment (except physiologic replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on trial.
- Known positive test for human immunodeficiency virus.
- Presence or history of viral hepatitis infection.
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of trial treatment with the following exceptions:
- Androgen-deprivation therapy with luteinizing hormone-releasing hormone/gonadotropin-releasing hormone (LHRH/GnRH) analogue (agonist/antagonist) is allowed.
- ARPIs (enzalutamide, abiraterone, apalutamide, darolutamide) require a minimum washout of 2 weeks prior to the first dose of xaluritamig.
- Prior prostate-specific membrane antigen (PSMA) radionuclide therapy cannot be given within 3 months prior to first dose of xaluritamig unless participant received \<2 cycles of therapy, in which case participant cannot...
- Any prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
- Any prior cluster of differentiation 3 (CD3)-directed therapy.
- Requirement for chronic systemic corticosteroid therapy (prednisone dose \>10 mg/day or equivalent) or any other immunosuppressive therapies (including anti TNFα therapies).
- Participation on any other xaluritamig trial, regardless of whether xaluritamig was administered.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Nashville, Tennessee, United States
- Irving, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States; Pittsburgh, Pennsylvania, United States; Sioux Falls, South Dakota, United States; Nashville, Tennessee, United States; Irving, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.