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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 3 of 32 sitesv8
  2. Site details revised at 1 of 32 sitesv7
  3. Site details revised at 2 of 32 sitesv6
  4. Study sites: 31 to 32v5
  5. Study sites: 29 to 31v4
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  1. Enrollment target: 50 to 200 Primary completion date: Dec 31, 2023 to Dec 31, 2027 · Study sites: 1 to 29 · Completion date: Aug 31, 2025 to Dec 31, 2028 · 3 morev3 Show 6 more changesShow less
    • Primary completion date: Dec 31, 2023 to Dec 31, 2027
    • Study sites: 1 to 29
    • Completion date: Aug 31, 2025 to Dec 31, 2028
    • Interventions: 120mg ABSK-011capsule (Drug), 180mg ABSK-011capsule (Drug), 240mg ABSK-011capsule (Drug), 320 mg ABSK-011capsule (Drug), 400mg… to ABSK-011 (Drug)
    • Eligibility criteria expanded, about 9 words
    • Study arms: 6 to 1

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Oct 31, 2022 to Dec 31, 2023 Completion date: Jan 31, 2023 to Aug 31, 2025v2 Show 1 more changeShow less
    • Completion date: Jan 31, 2023 to Aug 31, 2025
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an open-label phase 1 study with an escalation part and an expansion part.
Trial Details
NCT Number NCT04906434
Lead Sponsor Abbisko Therapeutics Co, Ltd
Conditions Advanced Liver Cancer
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov