A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
18 Years and older, Male and Female
ABSK021-101 (primary)
NCI-2020-05560
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.
Eligibility
- Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists
- ECOG (electrocorticogram) performance status 0~1
- Life expectancy = 3 months
- Adequate organ function and bone marrow function For patients with tenosynovial giant cell tumor (TGCT) :
- A diagnosis of TGCT [i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board);
- Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;
- Others
Treatment Sites in Georgia
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