End points
death, tumor
DISEASE, DISEASE PROGRESSION, SECONDARY, TUMOR
As Module 1A was a ‘first time in human’ safety study, initial efficacy was evaluated as a secondary endpoint using the DCR, defined as the percentage of patients with a complete response (CR), PR or stabilization of disease at first on treatment RECIST assessment. To allow for the evaluation of longer-term benefit, Module 1B-1 and Module 2A used the CBR as a secondary endpoint, defined as the percentage of patients with CR or PR or stabilization of disease for at least 24 weeks between enrollment and disease progression or death due to any cause. In addition, the ORR was assessed, defined as the percentage of patients who had at least 1 objective response (CR or PR) prior to any evidence of progression. RECIST V1.1 endpoints were assessed in the response evaluable population - defined as all patients who received ≥1 dose of samuraciclib and had a post-baseline tumor assessment. Statistical analyses of PFS using the Kaplan-Meier method were performed on the ITT population - defined as all enrolled patients. AEs were summarized from the Safety Population - defined as all patients who received at least 1 dose of samuraciclib - using the MedDRA system organ class (SOC), preferred term (PT), and graded according to CTCAE V5.0 (Supplementary Information).