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Number of participants with potentially clinically significant laboratory values.
Number of participants with potentially clinically significant ECG values.
Number of participants with potentially clinically significant vital sign values.
Number of participants with potentially clinically significant physical exam values.
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study IP, whether or not considered related to the study investigational product (IP). Note: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study IP. This includes events related to the comparator and events related to the (study) procedures.
A DLT is defined as any event meeting the DLT criteria excluding toxicities clearly related to disease progression or intercurrent illness or standard of care (SoC) regimens as determined by the investigator.
An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other medically important events.
ORR is defined as the proportion of participants whose best overall response is rated as complete response (CR) or partial response (PR) per RECIST v1.1.
DOR is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date of documented radiological disease progression per RECIST v1.1 or death in the absence of progression.
DCR is defined as the proportion of participants whose best overall response is rated as CR, PR or SD based on RECIST v1.1.
AUC will be recorded from the PK plasma samples collected.
Cmax will be recorded from the PK plasma samples collected.
Ctrough will be recorded from the PK plasma samples collected.
tmax will be recorded from the PK plasma samples collected.
Changes in KRAS G12D in tumor samples will be measured.