This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
JAB-3068 will be orally administered on a daily basis. Patients need to fast 2 hours before (6 hours for PK days) and 2 hours after each dosing.
HealthONE Clinic Services Oncology-Hematology
Denver, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Number of participants with dose limiting toxicities
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3068.
Time frame: up to 28-day per cycle
Number of participants with adverse events
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments
Time frame: Approximately 2 years
Area under the curve
Area under the plasma concentration time curve of JAB-3068
Time frame: Approximately 2 years
Cmax
Highest observed plasma concentration of JAB-3068
Time frame: Approximately 2 years
Tmax
Time of highest observed plasma concentration of JAB-3068
Time frame: Approximately 2 years
T1/2
Half life of JAB-3068
Time frame: Approximately 2 years
Objective response rate
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Time frame: Approximately 2 years
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Duration of response
DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.
Time frame: Approximately 2 years