NCT04192344

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor

A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.

Detailed description

The study will start with a dose escalation part of single-agent ABSK021 administered in repeated 28-day cycles in patients with advanced solid for safety and tolerability. The expansion part of oral ABSK021 at recommended dose of expansion (RDE) will be followed for further evaluating safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.

Conditions

• Neoplasms
• Tenosynovial Giant Cell Tumor

Interventions

Type	Name	Description
DRUG	ABSK021	ABSK021 oral capsule

Timeline

• Start date: 2020-01-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-12-10
• Last updated: 2026-03-19

Locations

17 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study