Status:
COMPLETED
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
Lead Sponsor:
Incyte Corporation
Conditions:
Biliary Tract Cancer (BTC)
Colorectal Cancer (CRC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2022
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT03314935
Start Date
November 21 2017
End Date
November 28 2022
Last Update
August 12 2025
Active Locations (10)
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1
University of Alabama
Birmingham, Alabama, United States, 35294-3300
2
USA Mitchell Cancer Center
Mobile, Alabama, United States, 36604
3
UC Davis - Comprehensive Cancer Centre
Sacramento, California, United States, 95817
4
Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060