Frontiers in oncology
A narrative review of adaptive Phase I/II clinical trial designs for drug combinations in oncology
By Wang J, Wu S and Yang J.
Abstract
Background
Adaptive Phase I/II designs can jointly use toxicity and efficacy information to guide dose allocation and regimen selection. These designs are particularly relevant for oncology drug-combination trials, where the optimal regimen may not coincide with the maximum tolerated dose.
Methods
We conducted a structured narrative review of adaptive Phase I/II designs for oncology drug combinations that use both toxicity and efficacy information for adaptive allocation or final regimen selection. PubMed was searched through April 16, 2026 using terms related to Phase I/II, seamless design, drug combinations, dose-finding and efficacy, optimal biological dose, dual-agent, efficacy-toxicity trade-off, utility-based dose-finding, and adaptive randomization. Google Scholar and reference lists were used for supplementary citation chasing, and ClinicalTrials.gov was searched for illustrative real-trial applications.