A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors
The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.
Phase 1/Phase 2
Phase 1: Participants with treatment-emergent adverse events (TEAE)
Phase 2: Participants with TEAEs
Biliary Tract Cancer (BTC)
Study Arms / Comparison Groups
Treatment Group A
Description: INCB001158 + FOLFOX
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
November 21, 2017
November 28, 2022
Primary Completion Date
November 28, 2022
Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors. - Presence of measurable disease per RECIST v1.1. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. - Resolution of treatment-related toxicities. - Adequate hepatic, renal, cardiac, and hematologic function. - Additional cohort-specific criteria may apply. Exclusion Criteria: - Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose. - Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug. - Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment. - Has received prior approved radiotherapy within 14 days of study therapy. - Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry. - Has an active autoimmune disease that has required systemic treatment in past 2 years. - Has an active infection requiring systemic therapy. - Has known active CNS metastases and/or carcinomatous meningitis. - Women who are pregnant or breastfeeding.
18 Years - N/A
Accepts Healthy Volunteers
Lance Leopold, MD, ,
Lance Leopold, MD, Study Director, Incyte Corporation