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The Study of ICP-248 in Patients With Mature B-cell Malignancies

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: 2 to 3 Interventions: ICP-248 (Drug), ICP-248+Orelabrutinib (Drug) to ICP-248 (Drug), ICP-248 (Drug), ICP-248 +Rituximab (Drug), ICP-248+Orelabrutinib (Drug), ICP-248+Orelabrutinib (Drug)… · Eligibility criteria expanded, about 21 words · Secondary endpoints: 12 to 11 · 1 morev7 Show 4 more changesShow less
    • Interventions: ICP-248 (Drug), ICP-248+Orelabrutinib (Drug) to ICP-248 (Drug), ICP-248 (Drug), ICP-248 +Rituximab (Drug), ICP-248+Orelabrutinib (Drug), ICP-248+Orelabrutinib (Drug)…
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 12 to 11
    • Study arms: 2 to 7

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment target: 105 to 191 Primary completion date: Aug 30, 2024 to Aug 30, 2025 · Interventions: ICP-248 (Drug) to ICP-248 (Drug), ICP-248+Orelabrutinib (Drug) · Eligibility criteria expanded, about 58 words · 2 morev6 Show 5 more changesShow less
    • Primary completion date: Aug 30, 2024 to Aug 30, 2025
    • Interventions: ICP-248 (Drug) to ICP-248 (Drug), ICP-248+Orelabrutinib (Drug)
    • Eligibility criteria expanded, about 58 words
    • Site details revised at 3 of 22 sites
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria revised Site details revised at 3 of 22 sitesv5 Show 1 more changeShow less
    • Site details revised at 3 of 22 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Site details revised at 12 of 22 sitesv4
  5. Primary endpoints revised (2) Study sites: 5 to 22 · Eligibility criteria expanded, about 20 wordsv3 Show 2 more changesShow less
    • Study sites: 5 to 22
    • Eligibility criteria expanded, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 5 · Start date changed from estimate of Feb 25, 2023 to Mar 9, 2023v2 Show 2 more changesShow less
    • Study sites: 1 to 5
    • Start date changed from estimate of Feb 25, 2023 to Mar 9, 2023
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination Therapy in Patients with Mature B-cell Malignancies.This study consists of two parts: Part 1 dose-finding period and Part 2 dose expansion period.
Trial Details
NCT Number NCT05728658
Lead Sponsor Beijing InnoCare Pharma Tech Co., Ltd.
Conditions Hematological Malignancies
Enrollment 191 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov