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A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 390 to 407v6
  2. Enrollment target: 290 to 390v5
  3. Study sites: 17 to 20v4
  4. Study sites: 1 to 17v3
  5. Trial status: Not Yet Recruiting to Recruiting Primary endpoints revised (4) · Study sites: 0 to 1 · Start date changed from estimate of Jul 8, 2024 to Jul 9, 2024 · 2 morev2 Show 5 more changesShow less
    • Primary endpoints revised (4)
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 8, 2024 to Jul 9, 2024
    • Secondary endpoints: details revised at 4 of 5 entries
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.
Trial Details
NCT Number NCT06500676
Lead Sponsor Genfleet Therapeutics (Shanghai) Inc.
Conditions KRAS G12D Mutations, Advanced Solid Tumors
Enrollment 407 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov