A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of INCB Combinations in Advanced Solid Tumors

What is the purpose of this trial?

This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 2 parts (Part 1a and Part 1b). Part 1a will evaluate a JAK inhibitor with JAK1 selectivity (INCB039110) in combination with an IDO1 inhibitor (epacadostat; INCB024360; Group A) and INCB039110 in combination with a PI3K-delta inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses for each combination. Once the recommended dose has been identified for each treatment group in Part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b).

Incyte Corporation

Dates: 03/30/2016 - 12/01/2017

Last Updated: 03/02/2017

Study HIC#: 1507016224