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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.
Epacadostat tablets will be administered orally, twice daily.
Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.
INCB050465 tablets will be administered orally once daily.
Unnamed facility
Duarte, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
New Haven, Connecticut, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
Huntersville, North Carolina, United States
Unnamed facility
Nashville, Tennessee, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
Houston, Texas, United States
...and 1 more locations
Number of Participants With Dose Limiting Toxicities (DLTs)
Safety and tolerability of the treatment groups.
Time frame: Baseline through 21 days
Objective response rate (ORR)
Tumor response rates in those subjects with measurable disease.
Time frame: Every 9 weeks for duration of study participation which is estimated to be 18 months
Progression Free Survival (PFS)
Progression-free survival, defined as the time from enrollment until the earliest date of disease progression.
Time frame: Every 9 weeks for duration of study participation which is estimated to be 18 months
Duration of response (DOR)
Duration of response determined by radiographic disease assessment.
Time frame: Every 9 weeks for duration of study participation which is estimated to be 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.