End points and assessments
death, Tumor, tumor
DISEASE PROGRESSION, TUMOR, TUMOR, DISEASE, SECONDARY
Safety was first analyzed by assessing DLTs in phase Ib. In the phase II study, the primary endpoint was ORR according to RECIST v1.1 per investigator assessment. Tumor assessment was performed every 6 weeks ( ± 7 days) within week 54 and then every 12 weeks ( ± 7 days). Patients who discontinued treatment for any reason other than disease progression or death should take tumor assessment on schedule until initiation of new anticancer treatment, death, radiographic progressive disease, loss to follow-up, or withdrawal of informed consent. Objective response should be re-evaluated within 4 weeks after first recorded. The secondary endpoints included PFS, OS, disease control rate (DCR), DoR, and time to response (TTR) according to RECIST v1.1 per investigator assessment.