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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK121-NX in Patients With Advanced Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 20, 2025 (before its estimated March 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv12
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 24 of 24 sitesv11 Show 1 more changeShow less
    • Site details revised at 24 of 24 sites
  3. Site details revised at 4 of 24 sitesv10
  4. Primary completion date: Mar 15, 2025 to Mar 15, 2026 Completion date: Jun 30, 2025 to Jun 30, 2026v9 Show 1 more changeShow less
    • Completion date: Jun 30, 2025 to Jun 30, 2026
  5. Study sites: 12 to 24v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 9 to 12v7
  2. Study sites: 8 to 9v6
  3. Study sites: 7 to 8v5
  4. Study sites: 2 to 7v4
  5. Start date changed from estimate of Jun 30, 2023 to Jun 26, 2023v3
  6. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 15, 2022 to Jun 30, 2023 · Study sites: 0 to 2v2 Show 2 more changesShow less
    • Start date: Dec 15, 2022 to Jun 30, 2023
    • Study sites: 0 to 2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 expansion. The study will start with a dose escalation of single-agent ABSK121-NX administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK121-NX at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.
Trial Details
NCT Number NCT05627063
Lead Sponsor Abbisko Therapeutics Co, Ltd
Conditions Solid Tumor
Enrollment 169 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov