A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor
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.
Detailed 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.
Arms & interventions
- DrugABSK021
ABSK021 oral capsule
Outcome measures
Primary
Incidence of DLTs
DLT(dose-limiting toxicity)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Incidence and Severity of AEs
Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
Time frame: Through study completion, an average of 6 months
Secondary
PFS
Time frame: From date of enrollment until the date of first documented progression or death, assessed up to 12 months
DoR
Time frame: From date of enrollment until the date of first documented progression or death, assessed up to 12 months
DCR
Time frame: 24 weeks post-dose
Cmax
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose
tmax
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose
Bioavailability
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose
Elimination half-life
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose
Eligibility criteria
Study locations (4)
Precision NextGen Oncology
Beverly Hills, California, 90212
SCRI at HealthOne
Denver, Colorado, 80218-1238
The Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
MD Anderson Cancer Center
Houston, Texas, 77030