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A Phase 1 Study of BHV-1530 in Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary endpoint(s) modifiedv13 Show 6 more changesShow less
    • Enrollment increased: 95 → 140 participants
    • Trial sites expanded: 13 → 17 locations
    • Trial arms changed: 1 → 2
    • Interventions: BHV-1530 (Drug) to BHV-1530 (Drug), Cemiplimab (Drug)
    • Eligibility criteria expanded, about 168 words
    • Secondary endpoints revised (25)
  2. Study sites: 12 to 13v12
  3. Eligibility criteria expanded, about 82 wordsv11
  4. Study sites: 10 to 12v10
  5. Study sites: 8 to 10v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 7 to 8v8
  2. Study sites: 5 to 7v7
  3. Study sites: 4 to 5v6
  4. Eligibility criteria expanded, about 248 words
    • Secondary endpoints: 17 to 25
    • Study title shortened, about 1 word
    v5
  5. Study sites: 1 to 4v4
  6. Start date changed from estimate of Mar 2025 to Mar 20, 2025v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase 1, first in human (FIH), Open-Label, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination with Other Anti-Cancer Agents in Adult Participants with Advanced or Metastatic Solid Tumors
Trial Details
NCT Number NCT06874335
Lead Sponsor Biohaven Therapeutics Ltd.
Conditions
(from sponsor)		 Solid Tumor
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov