RecruitingPhase 1

Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer

A Phase 1b, Open-label Study of Xaluritamig (AMG 509) in Adults With Metastatic Castration-resistant Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of xaluritamig at a planned dose and schedule. It is for adults with prostate cancer that has spread and keeps growing despite treatment to lower testosterone.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests must confirm prostate adenocarcinoma, a cancer that starts in gland cells. Mixed cancer types are not allowed.
  • Cancer must have spread to at least one spot shown on a CT, MRI, or bone scan within 28 days before joining.
  • Cancer must be getting worse, shown by rising PSA blood levels, growing or new tumors, or new cancer spots in bone.
  • You must have had surgery to remove the testicles, be taking treatment to lower testosterone, or both. Your testosterone must be below 50 ng/dL.
  • Cancer must have worsened after at least one hormone-blocking drug, such as enzalutamide, abiraterone, apalutamide, or darolutamide.
  • You must have received exactly one taxane chemotherapy treatment after the cancer became resistant to testosterone-lowering treatment. Earlier docetaxel treatment is also allowed.

Who can't join

  • Past cancer spread to the brain or spinal cord. Spread to their outer covering is allowed if treated, stable, and causing no symptoms.
  • Allergy to study treatments, their ingredients, or similar drugs; or a medical reason you cannot take high-dose steroids.
  • Another cancer that may shorten your life or affect study tests. Exceptions include adequately treated cancers with no disease for over 3 years, non-melanoma skin cancer, or surface-level bladder cancer.
  • An active disease where the immune system attacks the body that needed whole-body treatment in the past 2 years, except normal hormone replacement. Also excluded: needing immune-suppressing drugs during the study or ongoing steroids above 10 mg of prednisone daily or an equal dose.
  • A known positive HIV test, or a current or past viral hepatitis infection.
  • Cancer treatment within 28 days before the first study dose, with exceptions: ongoing testosterone-lowering LHRH/GnRH drugs are allowed; hormone-blocking ARPI drugs must stop at least 2 weeks before. PSMA-targeted radiation treatment must stop at least 3 months before, or 35 days before if fewer than 2 cycles were given.
  • Any past treatment targeting STEAP1 or CD3, proteins targeted by some cancer treatments.
  • Joining any other xaluritamig study in the past, even if you did not receive the drug.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 the smallest SOD since treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. * 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 received one, and only one, taxane therapy in the mCRPC setting. Exclusion Criteria: * 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 for \>3 years are eligible, as are participants with adequately treated non-melanoma skin cancer or superficial bladder cancer. * 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 have received PSMA radionuclide therapy within 35 days prior to first dose. * 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.

Study sites (12)

CO

NC

OH

PA

SD

TN

TX

VA