Study endpoints
toxicity, SD
DISEASE
The primary endpoints were dose‐limiting toxicity (DLT) and MTD of HS‐10352. Secondary endpoints included safety, pharmacokinetics, objective response rate (ORR), disease control rate (DCR), duration of response (DoR), PFS, and overall survival (OS).DLT was defined as any grade ≥4 hematologic or grade ≥3 non‐hematologic toxicity that occurred from the single dose on Day 1 of Cycle 0 up to the last dose in the first repeated dosing cycle, which was unrelated to the disease but associated with the study drug per investigator judgment according to CTCAE version 5.0. MTD was defined as either the highest tolerable dose at which DLT occurred in no more than one patient or as the intermediate dose between the intolerable dose (where DLT occurred in two or more patients) and the previously determined highest tolerable dose. At the intermediate dose level, DLT should occur in no more than one patient during subsequent assessments. ORR was defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR). DCR was defined as the proportion of patients with a confirmed CR, PR, or stable disease (SD).