Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04260022 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 62 to 242 Primary completion date: Jan 31, 2024 to Dec 27, 2029 · Study sites: 8 to 9 · Completion date: Jan 31, 2024 to Mar 31, 2030v24 Show 3 more changesShow less
    • Primary completion date: Jan 31, 2024 to Dec 27, 2029
    • Study sites: 8 to 9
    • Completion date: Jan 31, 2024 to Mar 31, 2030
  2. Primary completion date: Jan 31, 2023 to Jan 31, 2024v23
  3. Re-verified, no change to tracked fieldsv22
  4. Study description shortened, about 45 words Eligibility criteria shortened, about 1 wordv21 Show 1 more changeShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Site contacts updated at 1 of 8 sitesv20
Show 18 earlier versionsHide 18 earlier versions
  1. Enrollment target: 30 to 62 Primary completion date: Jun 30, 2022 to Jan 31, 2023 · Completion date: Jun 30, 2023 to Jan 31, 2024 · Interventions: Ascentage Pharma HQP1351 bioavailable inhibitor (Drug) to Ascentage Pharma HQP1351 bioavailable inhibitor (Drug), Blinatumomab (Drug) · 3 morev19 Show 6 more changesShow less
    • Primary completion date: Jun 30, 2022 to Jan 31, 2023
    • Completion date: Jun 30, 2023 to Jan 31, 2024
    • Interventions: Ascentage Pharma HQP1351 bioavailable inhibitor (Drug) to Ascentage Pharma HQP1351 bioavailable inhibitor (Drug), Blinatumomab (Drug)
    • Eligibility criteria expanded, about 54 words
    • Study description expanded, about 113 words
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  2. Site contacts updated at 1 of 8 sitesv18
  3. Site contacts updated at 1 of 8 sitesv17
  4. Primary completion date: Dec 30, 2021 to Jun 30, 2022 Study sites: 7 to 8 · Completion date: Dec 30, 2023 to Jun 30, 2023v16 Show 2 more changesShow less
    • Study sites: 7 to 8
    • Completion date: Dec 30, 2023 to Jun 30, 2023
  5. Site contacts updated at 1 of 7 sitesv15
  6. Site contacts updated at 3 of 7 sitesv14
  7. Eligibility criteria shortened, about 31 words Study description shortened, about 60 wordsv13 Show 1 more changeShow less
    • Study description shortened, about 60 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 6 to 7v12
  9. Site details revised at 1 of 6 sitesv11
  10. Study sites: 5 to 6v10
  11. Start date: Dec 1, 2019 to Jan 9, 2020v9
  12. Eligibility criteria expanded, about 363 words Study description expanded, about 20 words · Study title expanded, about 1 wordv8 Show 2 more changesShow less
    • Study description expanded, about 20 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 4 to 5v7
  14. Primary completion date: Dec 30, 2020 to Dec 30, 2021 Completion date: Dec 30, 2022 to Dec 30, 2023 · Site details revised at 1 of 4 sitesv6 Show 2 more changesShow less
    • Completion date: Dec 30, 2022 to Dec 30, 2023
    • Site details revised at 1 of 4 sites
  15. Study sites: 3 to 4v5
  16. Site details revised at 2 of 3 sitesv4
  17. Study sites: 1 to 3 Primary completion date: Jun 30, 2021 to Dec 30, 2020 · Interventions: Ascentage Pharma HQP-1351 bioavailable inhibitor (Drug) to Ascentage Pharma HQP1351 bioavailable inhibitor (Drug) · Eligibility criteria expanded, about 25 words · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Jun 30, 2021 to Dec 30, 2020
    • Interventions: Ascentage Pharma HQP-1351 bioavailable inhibitor (Drug) to Ascentage Pharma HQP1351 bioavailable inhibitor (Drug)
    • Eligibility criteria expanded, about 25 words
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  18. Primary completion date: Oct 30, 2020 to Jun 30, 2021 Primary endpoints revised (2) · Completion date: Oct 30, 2021 to Dec 30, 2022 · Eligibility criteria shortened, about 54 words · 2 morev2 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Completion date: Oct 30, 2021 to Dec 30, 2022
    • Eligibility criteria shortened, about 54 words
    • Study site revised
    • Study arms: 1 to 3

    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.
A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.
Trial Details
NCT Number NCT04260022
Lead Sponsor Ascentage Pharma Group Inc.
Conditions Leukemia, Myeloid, Chronic, Myeloid Leukemia, Chronic Myeloid Leukemia, Philadelphia Positive Acute Lymphoblastic Leukemia, B Cell Precursor Type Acute Leukemia
Enrollment 242 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov