This is a Phase 1/2a, open-label, multi-center study of JAB-3068 in Patients with advanced solid tumors.This study has two phases: dose escalation phase and dose expansion phase.
Dose escalation study phase is designed to determine the maximum tolerated dose (MTD) according to a 3+3 design and recommended phase II dose (RP2D) and to characterize the safety, tolerability, and pharmacokinetics (PK) profile of JAB-3068. Other dose regimens may be explored based on the analysis of emerging PK and safety data. at this study phase, JAB-3068 dministered orally once daily (QD) or twice daily (BID) or once every other day (QOD) in 28-day treatment cycles to adult patients with advanced solid tumors, Dose expansion study phase is designed to evaluate the antitumor activity(ORR and DOR) of JAB-3068 in patients with NSCLC, ESCC and HNSCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
126
25 mg,100 mg
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA Central Hospital
Beijing, Beijing Municipality, China
Number of participants with dose limiting toxicities
Number of participants with 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: At the end of Cycle 1 (each cycle is 28 days)
Objective response rate
ORR is defined as the proportion of participants with complete response or partial. the ORR of JAB-3068 in patients with ESCC, NSCLC and HNSCC will be evaluated separately in dose expansion
Time frame: Approximately 2 years
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. The DOR of JAB-3068 in patients with ESCC, NSCLC and HNSCC will be evaluated separately in dose expansion
Time frame: Approximately 2 years
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
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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) in dose escalation.
Time frame: Approximately 2 years
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 in dose escalation.
Time frame: Approximately 2 years