Clinical Trial

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

Active, Not Recruiting Phase 1
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.
Summary
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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2022-11-21; most recent amendment 2025-10-16.
Status change: Recruiting → Active, Not Recruiting 2025-09-08
Status change: Not Yet Recruiting → Recruiting 2023-06-19
Trial Details
NCT Number NCT05627063
Lead Sponsor Abbisko Therapeutics Co, Ltd
Conditions Solid Tumor
Enrollment 169 participants
Start Date 2023-06-26
Primary Completion 2026-03-15 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-20