Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

There are many treatment options for men with various stages of prostate cancer. Some treatments work well for a while but can cause medical problems in some men. Also, the cancer may come back after treatment. This is an early development study of VIR-5500 in men with prostate cancer. In this study, VIR-5500 will be given to people for the first time. VIR-5500 will either be given by itself or given together with one or more standard cancer treatments: enzalutamide, darolutamide and docetaxel. Some other cancer treatments may also be given with VIR-5500 during this study, depending on result

Trial Details

NCT ID
NCT05997615
Phase
PHASE1
Sponsor
Astellas Pharma Global Development, Inc.
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • VIR-5500
  • ARSI
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311
  • Irvine, California, United States|33.66946,-117.82311
  • Orange, California, United States|33.78779,-117.85311
  • Palo Alto, California, United States|37.44188,-122.14302

Key Eligibility Criteria

  • Inclusion Criteria Applicable to mCRPC Cohorts in Part 1 and PSMA-Targeted Radioligand-Naive mCRPC Cohort (Part 2 Cohort 2-2)
  • Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), o…
  • Have had prior bilateral orchiectomy and/or are receiving androgen deprivation therapy (ADT) and have a castrate level of serum testosterone (\< 50…
  • Have documented progressive mCRPC based on ≥ 1 of the following criteria (per PCWG3):

For full eligibility, visit ClinicalTrials.gov.

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