Study Design
REGRESSION, SOLID TUMORS
This was a first-in-human (FIH), phase I, open-label, multicenter, single-arm, dose-escalation study designed to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of M8891 in patients with advanced solid tumors (NCT03138538). An adaptive study design was applied, using a Bayesian two-parameter logistic regression model (BLRM). This study was designed to have two phases. Part 1, the monotherapy, dose-escalation phase, was completed according to protocol and is reported here. Part 2 of the study (combination of M8891 with cabozantinib) was not initiated; this was not due to safety concerns. Twenty-seven patients were enrolled from five sites in the United States between August 2017 (first patient visit) and September 2020 (last patient visit).This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, applicable International Conference on Harmonization Good Clinical Practice Guidelines, and other applicable laws and regulations. The protocol and all required associated documents were approved by the responsible Institutional Review Board or Independent Ethics Committee. All patients were required to provide written informed consent prior to enrollment.