NCT04906434

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor

A Phase 1, Open-Label Study of ABSK-011 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label phase 1 study with an escalation part and an expansion part.

Detailed description

The escalation part will evaluate the safety, tolerability, PK and recommended dose of expansion (RDE) of oral ABSK-011 in patients with advanced solid tumors. The expansion part of oral ABSK-011 at RDE will be followed for further evaluating safety and tolerability in patients with FGF19 overexpression advanced HCC. Preliminary antitumor activity will also be assessed.

Conditions

• Advanced Liver Cancer

Interventions

Type	Name	Description
DRUG	ABSK-011	During the escalation part, the administration of oral ABSK-011 will be guided by "3+3"design based on safety data collected until a maximum tolerated dose (MTD) has been identified. The first dose level will be administered as QD, and different dosing frequencies (e.g., BID) may be explored in subsequent doses depending on emerging safety and pharmacokinetic data. A separate food effect cohort may be conducted. In expansion part, patients will be treated at the selected RDE dose level.

Timeline

• Start date: 2020-02-26
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2021-05-28
• Last updated: 2026-04-07

Locations

32 sites across 3 countries: United States, China, Taiwan

Regulatory

• FDA-regulated drug study