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A Study of HQP1351 in Patients With GIST or Other Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2025 to Dec 2027 Completion date: Dec 31, 2026 to Dec 2028v16 Show 1 more changeShow less
    • Completion date: Dec 31, 2026 to Dec 2028
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2025v15
  3. Enrollment target: 60 to 100v14
  4. Primary completion date: Sep 30, 2023 to Dec 31, 2024 Completion date: Mar 31, 2024 to Dec 31, 2026v13 Show 1 more changeShow less
    • Completion date: Mar 31, 2024 to Dec 31, 2026
  5. Site contacts updated at 5 of 6 sitesv12
Show 10 earlier versionsHide 10 earlier versions
  1. Enrollment target: 40 to 60 Study sites: 5 to 6 · Secondary endpoints: details revised at 1 of 3 entriesv11 Show 2 more changesShow less
    • Study sites: 5 to 6
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Primary completion date: Sep 2021 to Sep 30, 2023 Enrollment target: 30 to 40 · Study sites: 6 to 5 · Completion date: Feb 2022 to Mar 31, 2024 · 2 morev10 Show 5 more changesShow less
    • Enrollment target: 30 to 40
    • Study sites: 6 to 5
    • Completion date: Feb 2022 to Mar 31, 2024
    • Eligibility criteria expanded, about 26 words
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 5 to 6 Primary completion date: Mar 2021 to Sep 2021 · Completion date: Oct 30, 2021 to Feb 2022v9 Show 2 more changesShow less
    • Primary completion date: Mar 2021 to Sep 2021
    • Completion date: Oct 30, 2021 to Feb 2022
  4. Primary completion date: Oct 30, 2020 to Mar 2021 Completion date: Oct 30, 2020 to Oct 30, 2021 · Eligibility criteria shortened, about 18 wordsv8 Show 2 more changesShow less
    • Completion date: Oct 30, 2020 to Oct 30, 2021
    • Eligibility criteria shortened, about 18 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary and study completion dates: Aug 30, 2019 to Oct 30, 2020 Trial status: Completed to Recruiting · Site details revised at 5 of 5 sites · Collaborators expanded, about 3 wordsv7 Show 3 more changesShow less
    • Trial status: Completed to Recruiting
    • Site details revised at 5 of 5 sites
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Recruiting to Completed Study sites: 4 to 5 · Primary completion date changed from estimate of Jul 15, 2019 to Aug 30, 2019 · Study completion date changed from estimate of Jul 15, 2020 to Aug 30, 2019v6 Show 3 more changesShow less
    • Study sites: 4 to 5
    • Primary completion date changed from estimate of Jul 15, 2019 to Aug 30, 2019
    • Study completion date changed from estimate of Jul 15, 2020 to Aug 30, 2019
  7. Enrollment target: 50 to 30 Primary endpoint revised · Study sites: 1 to 4 · Eligibility criteria expanded, about 64 words · 2 morev5 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 1 to 4
    • Eligibility criteria expanded, about 64 words
    • Study description shortened, about 8 words
    • Study arms: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

  8. Re-verified, no change to tracked fieldsv4
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 1 · Start date changed from estimate of Jul 15, 2018 to Jul 11, 2018v3 Show 2 more changesShow less
    • Study sites: 2 to 1
    • Start date changed from estimate of Jul 15, 2018 to Jul 11, 2018
  10. Secondary endpoints revised (3)v2 See this version in full on ClinicalTrials.gov ↗
  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 study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK/PD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.
Trial Details
NCT Number NCT03594422
Lead Sponsor Ascentage Pharma Group Inc.
Collaborators: HealthQuest Pharma Inc.
Conditions Gastrointestinal Stromal Tumor (GIST), Solid Tumor, Adult
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov