Clinical Trial

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors

Recruiting Phase 1
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Record status
This record was last updated August 12, 2024 (before its estimated April 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2022-02-08; most recent amendment 2024-08-08.
Status change: Not Yet Recruiting → Recruiting 2022-08-24
Trial Details
NCT Number NCT05244551
Lead Sponsor Abbisko Therapeutics Co, Ltd
Conditions Solid Tumor
Enrollment 85 participants
Start Date 2022-06-30
Primary Completion 2025-04-30 (estimated)
Study Completion 2025-04-30 (estimated)
Updated on ClinicalTrials.gov 2024-08-12