Study Endpoints
SD
DISEASE
The primary endpoint for dose escalation was the number of patients experiencing DLT during the first 28-day cycle of CB-103 and for the confirmatory phase, the incidence rate, severity, and relationship of AEs to CB-103. Secondary endpoints included assessment of clinical benefit rate [CBR; defined as achieving complete and/or partial response and/or stable disease (SD) at prespecified benchmarks], duration of response, progression-free survival (PFS) and overall survival (OS), and plasma pharmacokinetics.