drugset / Trial / NCT05244551

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

NCT05244551

Phase 1 Recruiting 85 enrolled Abbisko Therapeutics Co, Ltd
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2022-06-30
Primary completion
2025-04-30
Completion
2025-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject ABSK061 Unknown 5 mg Oral

Indications