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RecruitingPhase 1

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive 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 how safe xaluritamig is when given with darolutamide or abiraterone, and how well people handle the treatment. It is for people whose prostate cancer has spread to other parts of the body and still responds to treatment that lowers male hormones.

The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.

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.
  • The cancer must have already spread when first diagnosed, with no earlier diagnosis of prostate cancer that had not spread.
  • You must have started androgen deprivation therapy (ADT), which lowers male hormones, within 12 weeks before screening. This may be medicine or surgery to remove the testicles, with or without abiraterone or darolutamide.
  • At diagnosis, cancer must have spread to internal organs, or to at least 4 bone sites, with at least one outside the spine and pelvis.
  • A bone scan, CT scan, or MRI must show that the cancer has spread.
  • After starting ADT, there must be no recorded worsening of PSA after it reaches its lowest level. PSA is a blood marker used to track prostate cancer.
  • You must not have received docetaxel, a chemotherapy drug.

Who can't join

  • Cancer has spread to the brain or spinal cord. Cancer in their outer covering may be allowed if it is stable and causes no symptoms.
  • Side effects from past cancer treatment have not returned to mild levels or your usual health. Exceptions include hair loss, effects from ongoing hormone treatment, and stable, well-controlled effects approved by the study doctor and sponsor.
  • An autoimmune disease, where the immune system attacks the body, needed medicine to weaken the immune system in the past 2 years.
  • Within 7 days before the first study dose, symptoms, exams, or scans show a sudden or uncontrolled active infection, or an infection affecting the whole body.
  • Past prostate cancer treatment included STEAP1-targeted drugs, radiation-carrying drugs called radioligand therapy, PARP inhibitors, chemotherapy, aminoglutethimide, ketoconazole, or body-wide biologic treatment such as immunotherapy.
  • You took enzalutamide or apalutamide within 15 days before joining.
  • You need ongoing steroids above 10 mg of prednisone daily, or an equal dose of another steroid, or other medicines that weaken the immune system. An exception may apply if these are stopped, with proper dose reduction, within 7 days before treatment.
  • You had radiation to every site where the cancer has spread. Radiation to only some sites to ease symptoms is allowed.

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

Official eligibility criteria

Inclusion Criteria: * Participants must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted. * Participants must have at the time of diagnosis: * De novo (synchronous) mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer, AND started ADT (LHRH agonist/antagonist or orchiectomy) with or without ARPI (defined as abiraterone OR darolutamide) as SOC, first treatment with ADT should be no longer than 12 weeks before screening. Prior docetaxel treatment is not permitted. * Participants must have at the time of diagnosis: * High-volume metastatic disease defined as presence of visceral metastasis or metastases, and/or ≥ 4 bone metastases with at least one outside of the vertebral column and pelvis. * Documented metastatic disease either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan. * No documented PSA progression following the initial PSA nadir after starting ADT. Exclusion Criteria: * Prior history of central nervous system (CNS) metastases. Note: Participants with asymptomatic and clinically stable dural metastases are eligible. * Unresolved toxicities from prior anti-tumor therapy (excluding those related to ongoing ADT and ARPI) not having resolved to Common Terminology Criteria for Adverse events (CTCAE) version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor. * 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 or systemic infection within 7 days prior to the first dose of study treatment. * Prior six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy. * Prior radioligand therapy (RLT), poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, cytotoxic chemotherapy, aminoglutethimide or ketoconazole for prostate cancer, or any prior systemic biologic therapy, including immunotherapy for prostate cancer. * Prior enzalutamide or apalutamide within 15 days prior to enrolment. * Requirement for chronic systemic corticosteroid therapy (prednisone dose greater than 10 mg per day or local equivalent) or any other immunosuppressive therapies (including anti TNFα therapies) unless stopped (with adequate tapering) within 7 days prior to dosing. * Prior radiotherapy to all metastatic sites of disease. Radiotherapy to some sites of metastatic disease for palliation will be permitted.

Study sites (8)

CA

MA

MN

OH

PA

SC

TN