To evaluate the safety and tolerability of JAB-3068 administered in investigational regimens in adult participants with advanced solid tumors.
To assess the safety and tolerability and determine the recommended phase 2 dose (RP2D) of JAB-3068 in combination with PD1 inhibitor in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
JAB-3068 administrated orally as a tablet.
JS001 administrated as an intravenous(IV) infusion.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Number of participants with dose limiting toxicities
Incidence of dose limiting toxicities (DLTs) . 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 and JS001.
Time frame: 24 months
Objective response rate (ORR)
ORR is defined as the proportion of participants with complete response or partial response (CR+PR).
Time frame: 24 months
Plasma concentration (Cmax)
Highest observed plasma concentration of JAB-3068 and JS001
Time frame: 24 months
Time to achieve Cmax (Tmax)
Time of highest observed plasma concentration of JAB-3068 and JS001
Time frame: 24 months
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration time curve of JAB-3068 and JS001
Time frame: 24 months
Duration of response ( DCR )
DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).
Time frame: 24 months
Progression-free survival (PFS)
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.
Time frame: 24 months
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Duration of response ( DOR )
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: 24 months
Overall survival (OS)
OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor.
Time frame: 24 months
Number of Participants with Treatment-related Adverse Events(TRAE)
TRAE is defined as the AES that the casual relationship of the AE is ralated to investigational drug.
Time frame: 24 months