Endpoints
death, DLTs, tumor, bone loss, intercurrent illness
DISEASE PROGRESSION, ADVERSE EVENT, TUMOR, BONE LOSS, DISEASE, SECONDARY
The primary endpoints of the phase Ib study were the incidence of DLTs and exposure to WNT974 and encorafenib as measured by PK parameters. A DLT was defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurred within the first 28 days of treatment with WNT974 + encorafenib + cetuximab. The secondary endpoints for this study included the objective response rate (ORR; RECIST 1.1), disease control rate (DCR), and frequency and severity of AEs (Common Terminology Criteria for Adverse Events v4.03).Tumor assessments were performed at baseline (screening) and every 6 weeks after starting study treatment until disease progression, initiation of subsequent antineoplastic therapy, or death, whichever occurred first. End-of-treatment tumor assessment was conducted within 14 days of receiving the last dose or treatment discontinuation. Safety was assessed throughout the study and included physical examinations, vital signs, weight, performance status evaluation, laboratory evaluations, dermatologic evaluations, ophthalmological examinations, bone loss assessments, cardiac assessments, and documentation of all non-serious and serious AEs (SAEs).