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Number of participants with AEs and SAEs, including findings from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
RDFE of BG-60366 will be determined based upon the MTD or MAD.
Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, and laboratory assessments as needed.
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
ORR is defined as the percentage of participants who had confirmed CR or PR assessed by the investigator using RECIST v1.1.
DOR is defined as the time from the first determination of objective response that is confirmed by the subsequent assessment until the first documentation of disease progression or death, whichever comes first.
TTR is defined as the time from the date of the first dose of study drugs to the date of teh first determination of objective response that is confirmed by the subsequent assessment.
PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of disease progression assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
DCR is defined as the percentage of participants with the best overall response of confirmed CR, PR, or stable disease assessed.