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A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 6 of 16 entries
    • Site details revised at 1 of 17 sites
  2. Eligibility criteria expanded, about 10 wordsv14
  3. Enrollment target: 280 to 500
    • Primary endpoints revised (5)
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 15 to 16
    v13
  4. Study sites: 14 to 17v12
  5. Study sites: 12 to 14v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary endpoints revised (5)
    • Interventions: BHV-1510 (Drug), BHV-1510 (Drug), Cemiplimab (Drug) to BHV-1510 (Drug), BHV-1510 (Drug), BHV-1510 (Drug), Cemiplimab (Drug), Cemiplimab (Drug)
    • Eligibility criteria shortened, about 16 words
    • Secondary endpoints: 10 to 15
    v10
  2. Study sites: 5 to 12v9
  3. Primary endpoints revised (5)v8 Show 5 more changesShow less
    • Enrollment target: 220 to 280
    • Interventions: Cemiplimab (Drug), PBI-410 (Drug) to BHV-1510 (Drug), BHV-1510 (Drug), Cemiplimab (Drug)
    • Eligibility criteria revised
    • Secondary endpoints revised (10)
    • Study description revised
  4. Study title expanded, about 2 wordsv7
  5. Primary endpoints revised (5)v6 Show 6 more changesShow less
    • Enrollment target: 170 to 220
    • Interventions: PBI-410 (Drug) to Cemiplimab (Drug), PBI-410 (Drug)
    • Eligibility criteria expanded, about 121 words
    • Secondary endpoints revised (10)
    • Study description expanded, about 17 words
    • Study arms: 1 to 2
  6. Lead sponsor: Pyramid Biosciences to Biohaven Therapeutics Ltd.v5
  7. Study sites: 3 to 5v4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2024 to Apr 22, 2024
    • Site details revised at 3 of 3 sites
    v3
  9. Study sites: 0 to 3v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 1/2, first in human (FIH), open-label, multicenter study of BHV-1510 monotherapy and in Combination with Cemiplimab in participants with previously treated, advanced solid tumors.
Trial Details
NCT Number NCT06384807
Lead Sponsor Biohaven Therapeutics Ltd.
Conditions
(from sponsor)		 Solid Tumor
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov