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Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Site details revised at 10 of 10 sites
    v5
  2. Primary completion date: Feb 2025 to Jan 2028
    • Enrollment target: 140 to 170
    • Study sites: 8 to 10
    • Eligibility criteria expanded, about 28 words
    v4
  3. Site details revised at 3 of 8 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2022 to Jan 11, 2023
    • Site details revised at 8 of 8 sites
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a Phase1 study to assess the safety, PK, PD and efficacy of HM97662, EZH1/2 dual inhibitor, in solid tumors. The study is comprised of Dose-Escalation Part followed by randomized Dose-Ranging Part and Dose-Expansion Part. Dose-Escalation Part is planned with a 3+3 Dose-Escalation design and is to establish the MTD or RD for randomized Dose-Ranging Part. Dose-Ranging Part is designed mainly to further evaluate safety and preliminary efficacy of HM97662 monotherapy in subjects with specific genomic alterations to more precisely determine the potential RP2D that are to be tested in a Dose-Expansion Part. Dose-Expansion Part is designed to assess the potential efficacy of HM97662 monotherapy when administered at the RP2D to subjects in indication-specific expansion cohorts.
Trial Details
NCT Number NCT05598151
Lead Sponsor Hanmi Pharmaceutical Company Limited
Conditions
(from sponsor)		 Advanced or Metastatic Solid Tumors
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov