Adding xaluritamig to androgen receptor pathway inhibitors for metastatic hormone-sensitive prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial gives escalating doses of xaluritamig together with either darolutamide or abiraterone to determine safety and tolerability in men with de novo high-volume metastatic hormone-sensitive prostate cancer. Participants must have histologically confirmed prostate adenocarcinoma, have started androgen deprivation therapy within 12 weeks, and may not have received prior docetaxel. The study will closely monitor adverse events, laboratory values, and tolerability to identify a recommended dose for future testing. Treatment and follow-up are conducted at specialized U.S. cancer centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California San Francisco
  San Francisco, California, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting
• Thomas Jefferson University
  Philadelphia, Pennsylvania, United States Recruiting
• University of Pittsburgh Medical Center Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• How darolutamide with hormone therapy works for advanced prostate cancer in German practice

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• PSA‑triggered intermittent relugolix plus ARPI for metastatic hormone‑sensitive prostate cancer

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• Tulmimetostat with darolutamide or abiraterone for metastatic hormone-sensitive prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.