A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor
Abbisko Therapeutics Co, Ltd
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) : 1. 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…
Interventions
- DrugABSK021
ABSK021 oral capsule
Locations (17)
- Precision NextGen OncologyBeverly Hills, California
- SCRI at HealthOneDenver, Colorado
- The Winship Cancer Institute of Emory UniversityAtlanta, Georgia
- MD Anderson Cancer CenterHouston, Texas
- Beijing Jishuitan HospitalBeijing, Beijing Municipality
- The First Affiliated Hospital of Sun Yat-sen UniversityGuangdong, Guangzhou