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

The study will be conducted in 4 parts and will commence with dose escalation of VIR-5500 as a monotherapy (Part 1), followed by combination escalation (Part 3a), monotherapy dose expansion (Part 2) and combination dose expansion (Part 4a). * Part 1 (Monotherapy Dose Escalation): Single-agent VIR-5500 dose escalation * Part 2 (Monotherapy Dose Expansion): Single-agent VIR-5500 dose expansion * Part 3 (Combination Dose Escalation): VIR-5500 plus another therapeutic agent dose escalation Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor

Trial Details

NCT ID
NCT05997615
Phase
PHASE1
Sponsor
Vir Biotechnology, Inc.
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • VIR-5500
  • ARSI
Locations (sample)
  • Palo Alto, California, United States|37.44188,-122.14302
  • Houston, Texas, United States|29.76328,-95.36327
  • Fairfax, Virginia, United States|38.84622,-77.30637
  • Seattle, Washington, United States|47.60621,-122.33207
  • Melbourne, Australia|-37.814,144.96332

Key Eligibility Criteria

  • Applicable to Parts 1 and 2
  • Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), o…
  • Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3)
  • PSA level ≥ 1 ng/mL that has increased on ≥ 2 successive occasions ≥ 1 week apart

For full eligibility, visit ClinicalTrials.gov.

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