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

Active:	Yes
Cancer Type:	Germ Cell Tumor	NCT ID:	NCT04192344
Trial Phases:	Phase I	Protocol IDs:	ABSK021-101 (primary) NCI-2020-05560
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Abbisko Therapeutics Co, Ltd
NCI Full Details:	http://clinicaltrials.gov/show/NCT04192344

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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