Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors
Status:
Terminated
Trial end date:
2019-08-18
Target enrollment:
Participant gender:
Summary
This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid
tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2). Part 1a will
evaluate a JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1
inhibitor (epacadostat; INCB024360; Group A) and Itacitinib 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). In Part 2,
additional expansion cohorts will be enrolled to further evaluate lower doses of itacitinib
and INCB050465 in subjects with select tumor types.