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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
276
ABSK021 oral capsule
Precision NextGen Oncology
Beverly Hills, California, United States
RECRUITINGIncidence 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
PFS
Progression-Free Survival (PFS)
Time frame: From date of enrollment until the date of first documented progression or death, assessed up to 12 months
DoR
Duration of Response (DoR)
Time frame: From date of enrollment until the date of first documented progression or death, assessed up to 12 months
DCR
Disease Control Rate (DCR)
Time frame: 24 weeks post-dose
Cmax
The peak plasma concentration of a drug after administration
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose
tmax
Time to reach Cmax
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose
Bioavailability
The systemically available fraction of a drug
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SCRI at HealthOne
Denver, Colorado, United States
The Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
COMPLETEDMD Anderson Cancer Center
Houston, Texas, United States
COMPLETEDBeijing Jishuitan Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Sun Yat-sen University
Guangdong, Guangzhou, China
RECRUITINGHebei Medical University Third Hospital
Shijiazhuang, Hebei, China
COMPLETEDHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou Universtity
Zhengzhou, Henan, China
COMPLETEDJiangsu Province Hospital
Nanjing, Jiangsu, China
ACTIVE_NOT_RECRUITING...and 7 more locations
Elimination half-life
The time required for the concentration of the drug to reach half of its original value
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose