NCT04964375

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor

A Phase 1, Open-Label Study of ABSK043 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, Open-Label Study of ABSK043 to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced Solid Tumor. Preliminary antitumor activity will also be assessed. Investigate the pharmacodynamics (PD) effects and Investigate the metabolites of oral ABSK043

Detailed description

The study will start with a dose escalation part of single-agent ABSK043 administered in repeated 28-day cycles in patients with advanced solid for safety and tolerability. The expansion part of oral ABSK043 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

Interventions

Type	Name	Description
DRUG	ABSK043 oral capsule	ABSK043 is a novel, oral small molecule inhibitor of PD-L1

Timeline

• Start date: 2021-08-31
• Primary completion: 2022-10-23
• Completion: 2023-03-23
• First posted: 2021-07-16
• Last updated: 2022-04-27

Locations

3 sites across 1 country: Australia