Study Comparing Xaluritamig Plus Abiraterone to Other Treatments in Patients with Advanced Prostate Cancer

Sponsor: Amgen

Sponsor score: 60

ClinicalTrials ID:NCT07213674

This clinical trial is comparing the effectiveness of a new treatment combination, xaluritamig plus abiraterone, against standard treatments chosen by doctors for patients with advanced prostate cancer that has spread and is resistant to hormone therapy.

Patient Parameters

Program Overview

The main goal of this study is to see if the combination of xaluritamig and abiraterone can help patients with advanced prostate cancer live longer compared to other standard treatments like docetaxel, cabazitaxel, or abiraterone alone. This study is for patients whose cancer has spread and is no longer responding to hormone therapy, but who have not yet received chemotherapy for their condition.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent before starting any study-related activities.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of prostate cancer that has spread and is resistant to hormone therapy.
  • Must have at least one cancerous lesion visible on a scan taken within 28 days before joining the study.
  • Must show signs of cancer progression, such as increased PSA levels or new lesions on scans.
  • Must have had surgery to remove the testicles or be on ongoing hormone therapy to lower testosterone levels.
  • Must have previously tried one androgen receptor pathway inhibitor (like enzalutamide, apalutamide, or darolutamide) and experienced disease progression.
  • If planning to receive cabazitaxel, must have had no more than 6 cycles of docetaxel in the past.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have adequate organ function.

Exclusion Criteria

  • History of cancer spread to the brain or spinal cord.
  • Unresolved side effects from previous cancer treatments, except for hair loss or stable, well-controlled side effects.
  • Previous treatment with STEAP1-targeted therapy.
  • Previous intolerance or progression on abiraterone.
  • Previous chemotherapy for advanced prostate cancer or more than 6 cycles of docetaxel for hormone-sensitive prostate cancer.
  • Any cancer treatment, immunotherapy, or experimental drug within 4 weeks before starting the study, except for hormone therapy.
  • Previous PSMA radioligand therapy within 3 months before starting the study.
  • Previous radionuclide therapy within 2 months before starting the study.
  • Previous palliative radiotherapy within 2 weeks before starting the study, unless fully recovered from side effects.
  • Concurrent use of chemotherapy, ARPI, immunotherapy, radioligand therapy, PARP inhibitors, biological therapy, or experimental therapy.
  • Recent vaccination with live or live-attenuated vaccines within 4 weeks before starting the study.

Locations

FACILITYZIPCITYSTATE
City of Hope National Medical Center91010DuarteCalifornia
City of Hope Orange County Lennar Foundation Cancer Center91010DuarteCalifornia
Hightower Clinical73102Oklahoma CityOklahoma

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