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A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 27, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Dec 31, 2024 to Dec 2025 Trial status: Recruiting to Active, Not Recruiting · Site details revisedv4 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jun 2021 to Dec 31, 2024 · Start date changed from estimate of Jan 2019 to Jul 18, 2019 · Study sites: 0 to 1 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Jun 2021 to Dec 31, 2024
    • Start date changed from estimate of Jan 2019 to Jul 18, 2019
    • Study sites: 0 to 1
    • Completion date: Dec 2021 to Dec 31, 2024
  3. Eligibility criteria expanded, about 2 words Study description expanded, about 1 wordv2 Show 1 more changeShow less
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 was an open-label Phase I study. The primary objective of the study was to assess safety, tolerability, efficacy, and pharmacokinetic characteristics of BPI-16350 in different dose groups.
Trial Details
NCT Number NCT03791112
Lead Sponsor Betta Pharmaceuticals Co., Ltd.
Conditions Advanced Solid Cancer
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov