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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 4 → 5 primary endpoints
See other at-risk trials from Astellas Pharma Global Development, Inc.

Record History

  1. Trial sites expanded: 13 → 22 locations Eligibility criteria expanded, about 18 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 18 words
  2. Study sites: 12 to 13v17
  3. Primary endpoint(s) modified Sponsor changed: Vir Biotechnology, Inc. to Astellas Pharma Global Development, Inc. · Interventions: ARSI (Combination Product), VIR-5500 (Drug) to Androgen receptor signaling inhibitor (ARSI) (Drug), VIR-5500 (Drug) · Collaborators expanded, about 3 wordsv16 Show 3 more changesShow less
    • Sponsor changed: Vir Biotechnology, Inc. to Astellas Pharma Global Development, Inc.
    • Interventions: ARSI (Combination Product), VIR-5500 (Drug) to Androgen receptor signaling inhibitor (ARSI) (Drug), VIR-5500 (Drug)
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Enrollment increased: 390 → 437 participants Study sites: 10 to 12 · Interventions: Darolutamide (Combination Product), Enzalutamide (Combination Product), VIR-5500 (Drug) to ARSI (Combination Product), VIR-5500 (Drug) · Eligibility criteria expanded, about 47 words · 1 morev15 Show 4 more changesShow less
    • Study sites: 10 to 12
    • Interventions: Darolutamide (Combination Product), Enzalutamide (Combination Product), VIR-5500 (Drug) to ARSI (Combination Product), VIR-5500 (Drug)
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 10 of 10 entries

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 9 to 10v14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 8 to 9v13
  2. Phase: Phase 1/2 to Phase 1 Enrollment target: 215 to 390 · Primary endpoints revised (4) · Interventions: AMX-500 (SAR446329) (Drug) to Darolutamide (Combination Product), Enzalutamide (Combination Product), VIR-5500 (Drug) · 5 morev12 Show 8 more changesShow less
    • Enrollment target: 215 to 390
    • Primary endpoints revised (4)
    • Interventions: AMX-500 (SAR446329) (Drug) to Darolutamide (Combination Product), Enzalutamide (Combination Product), VIR-5500 (Drug)
    • Eligibility criteria expanded, about 86 words
    • Secondary endpoints: 11 to 10
    • Site details revised at 3 of 8 sites
    • Study arms: 2 to 4
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Lead sponsor: Amunix, a Sanofi Company to Vir Biotechnology, Inc.v11
  4. Eligibility criteria revisedv10 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 6 to 8v9
  6. Study sites: 5 to 6v8
  7. Study sites: 4 to 5v7
  8. Study sites: 3 to 4v6
  9. Study sites: 1 to 3v5
  10. Start date: Aug 29, 2023 to Aug 10, 2023v4
  11. Start date changed from estimate of Aug 17, 2023 to Aug 29, 2023v3
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Interventions: AMX-500 (Drug) to AMX-500 (SAR446329) (Drug)v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Interventions: AMX-500 (Drug) to AMX-500 (SAR446329) (Drug)
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 (ARSI) * Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion Part 4a (Combination Dose Expansion): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI)
Trial Details
NCT Number NCT05997615
Lead Sponsor Astellas Pharma Global Development, Inc.
Collaborators: Vir Biotechnology, Inc.
Conditions Hormone-refractory Prostate Cancer
Enrollment 437 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov