Statistical Analysis
Approximately 15 patients were planned to be enrolled in the phase Ib dose-escalation part of the study for the model to have reasonable operating characteristics relating to its MTD recommendation. The full analysis set (FAS) comprised all patients who received at least one full or partial dose of the assigned combination of drugs. The safety analysis set included all patients from the FAS who had at least one valid post-baseline safety assessment. The dose-­determining set consisted of all patients in the safety analysis set who either met the minimum exposure criterion (met if the patient received at least 21 of the 28 planned daily oral doses of WNT974 and encorafenib in the first 28 days of dosing, at least 50% [14 out of 28 days] of the planned combination doses of WNT974 and encorafenib administered together, and must have received the planned cetuximab loading dose and 2 additional planned cetuximab doses during the first 28 days of the study) and had sufficient safety evaluations (patients who did not experience a DLT during the first cycle if they had been observed for ≥28 days following the first dose and were considered by the Sponsor and Investigators to have enough safety data to conclude that a DLT did not occur) or who experienced a DLT during cycle 1. ORRs and DCRs were summarized using 95% CIs based on the exact binomial distribution.