Safety and Preliminary Efficacy Analyses
tumor, MET-positive tumors, cancer, SD, PD
DISEASE, CANCER, TUMOR
Safety analyses were descriptive. With respect to primary objectives and endpoints, no specific hypotheses were tested statistically. The primary focus was on determining the safety profile and RP2D, and the identification of a range of biologically active doses and PK of OMO-1 in patients with cancer. Safety, PK, and PD biomarker data were reviewed on an ongoing basis in line with the cohort progression criteria by the Safety Review Committee (SRC). Preliminary efficacy of OMO-1 by RECIST 1.1. was assessed locally. The best overall percentage change in tumor size is defined as the percentage change from baseline value that represents the largest decrease or smallest increase (data as provided by local assessment). The clinical benefit rate is derived as the proportion of patients with a partial response or a duration of stable disease (SD) of at least 8 weeks. Initially, the design in Module 1 Part A included parallel cohorts of patients with MET-positive tumors per dose level. Eventually, these patients were analyzed in Part B in expansion cohorts. Therefore, patients in Part B have received either 200 mg or 250 mg BID.