A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
Completed · Phase 1/Phase 2
Conditions studied: Biliary Tract Cancer (BTC), Colorectal Cancer (CRC), Endometrial Cancer, Gastroesophageal Cancer (GC), Ovarian Cancer, Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT03314935
- Run by
- Incyte Corporation
- People needed
- 149
- Starts
- 2017-11-21
- Expected to finish
- 2022-11-28
- Last updated by the study team
- 2025-08-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Alabama — Birmingham, Alabama, United States
- USA Mitchell Cancer Center — Mobile, Alabama, United States
- UC Davis - Comprehensive Cancer Centre — Sacramento, California, United States
- Northwest Georgia Oncology Centers — Marietta, Georgia, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- START San Antonio — San Antonio, Texas, United States
- Grand Hopital de Charleroi - Department of Medical Oncology — Brussels, Belgium
- Institut Jules Bordet - Clinical Trials Conduct Unit — Brussels, Belgium
- UCL Cancer Institute — London, United Kingdom
- The Christie NHS Foundation Trust — Manchester, United Kingdom
Full record on ClinicalTrials.gov
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