To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
311
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase
Number of participants with dose limiting toxicities
Time frame: first 21 days
Number of participants with adverse events
Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria
Time frame: up to 3 years
Overall response rate (ORR) by IRC (independent review committee)
ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1
Time frame: up to 3 years
Overall response rate (ORR) by investigator
ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1
Time frame: up to 3 years
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: up to 3 years
Disease Control Rate ( DCR )
DCR is defined as percentage of participants with complete response (CR), partial response (PR), and stable disease(SD) per RECIST v1.1
Time frame: up to 3 years
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 per RECIST v1.1, which occurs first
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Time frame: up to 3 years
Time to response (TTR)
Time from patient randomization (first treatment) to first response per RECIST 1.1 criteria
Time frame: up to 3 years
Peak Plasma Concentration (Cmax)
Cmax of JAB-21822 will be measured by using plasma PK samples
Time frame: up to 3 years