Seamless monotherapy-combination phase I dose-escalation model-based design.

ABSTRACT: Phase I dose-escalation studies for a single-agent and combination of anti-cancer agents have explored various model-based designs to guide identification of a maximum tolerated dose and recommended phase II dose. This work describes a parallel approach to dose escalation to expedite identification of maximum tolerated doses both for an anti-cancer agent as monotherapy and in combination with another agent. We develop a three-parameter Bayesian logistic regression model that allows for more efficient use of information between monotherapy and combination parts of the study. The model allows the monotherapy and combination data to drive dose escalation of the combination of treatments, reflecting the known dose-toxicity relationship between the monotherapy and combination setting. Through a

SUBMITTER: Daniells L 

PROVIDER: S-EPMC12318161 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature