A Phase 1 Study of SHR2554 in Subjects With Relapsed or Refractory Mature Lymphoid Neoplasms

StatusUnknown
PhasePhase 1
Started

Record status This record was last updated October 1, 2024 (before its estimated February 14, 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Primary completion date: Feb 14, 2023 to Feb 14, 2026v8 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 231 to confirmed 272
    • Study completion date: Aug 14, 2023 to Aug 14, 2026
    • Site details revised
  3. Primary endpoints revised (3)
    • Secondary endpoints: 21 to 18
    v7
  4. Enrollment target: 120 to 231v6 Show 5 more changesShow less
    • Primary completion date: Jun 2022 to Feb 14, 2023
    • Primary endpoints: 2 to 3
    • Study completion date: Jun 2023 to Aug 14, 2023
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 19 to 21
  5. Enrollment target: 42 to 120
    • Primary completion date: Sep 2020 to Jun 2022
    • Study completion date: Sep 2020 to Jun 2023
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date changed from estimate of Aug 10, 2018 to Aug 14, 2018v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 24, 2018 to Aug 10, 2018
    • Site details revised
    v3
  3. Primary endpoints revised (2)
    • Secondary endpoints revised (19)
    • Study title shortened, about 8 words
    v2
  1. Study First Submitted
  • 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 multicenter, single-arm, open-label, dose escalation and dose expansion study of enhancer of zeste homolog 2 (EZH2 ) inhibitor SHR2554. This study will assess the tolerability, safety, pharmacokinetics, and preliminary anti-tumor activity of SHR2554 in participants with relapsed or refractory mature lymphoid neoplasms in part I, and the the efficacy in PTCL patients will be studied in Part II.
Trial Details
NCT Number NCT03603951
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Collaborators: Peking University Cancer Hospital & Institute
Conditions
(from sponsor)		 Relapsed or Refractory Mature Lymphoid Neoplasms
Related terms Recurrence
Enrollment 272 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov