This study is to evaluate the safety and tolerability of JAB-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring KRAS G12C mutation.
The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 monotherapy to determine the MTD and PR2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 administered alone and combination with cetuximab during Dose Expansion phase in adult participants with advanced solid tumors harboring KRAS G12C mutation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Administered orally
Administered orally
Administered orally
Mayo Clinc
Phoenix, Arizona, United States
Mayo Clinc
Scottsdale, Arizona, United States
Mayo Clinc
Jacksonville, Florida, United States
University of Utah
Salt Lake City, Utah, United States
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Dose Escalation and Dose Expansion phase: 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 4 years
Dose Expansion phase: Overall response rate (ORR)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
Time frame: Up to 4 years - from baseline to RECIST confirmed Progressive Disease
Dose Expansion phase: Duration of response ( DOR )
DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to 4 years
Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)
Cmax of JAB-21822 alone or JAB-21822 plus cetuximabn will be measured by using plasma PK samples
Time frame: Up to 4 years
Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC)
AUC of JAB-21822 alone or JAB-21822 plus cetuximab will be measured by using plasma PK samples
Time frame: Up to 4 years
Dose Escalation phase: Overall response rate (ORR)
The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.
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Administered IV
Time frame: Up to 4 years - from baseline to RECIST confirmed Progressive Disease
Dose Escalation phase: Duration of response ( DOR )
DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to 4 years
Dose Escalation and Dose Expansion phase: Disease Control Rate ( DCR )
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease(SD) per CTCAE v1.1
Time frame: Up to 4 years
Dose Escalation and Dose Expansion phase: 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 per CTCAE v1.1 or death which occurs first
Time frame: Up to 4 years