A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
NCT ID: NCT03314935
Last Updated: 2025-08-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
149 participants
INTERVENTIONAL
2017-11-21
2022-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group A
INCB001158 + FOLFOX
INCB001158
Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
Oxaliplatin
Oxaliplatin administered intravenously at the protocol-defined dose and schedule.
Leucovorin
Leucovorin at the protocol-defined dose and regimen.
5-Fluorouracil
5-Fluorouracil at the protocol-defined dose and regimen.
Treatment Group B
INCB001158 + gemcitabine/cisplatin
INCB001158
Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
Gemcitabine
Gemcitabine at the protocol-defined dose and regimen.
Cisplatin
Cisplatin at the protocol-defined dose and regimen.
Treatment Group C
INCB001158 + paclitaxel
INCB001158
Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
Paclitaxel
Paclitaxel at the protocol-defined dose and regimen.
Interventions
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INCB001158
Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
Oxaliplatin
Oxaliplatin administered intravenously at the protocol-defined dose and schedule.
Leucovorin
Leucovorin at the protocol-defined dose and regimen.
5-Fluorouracil
5-Fluorouracil at the protocol-defined dose and regimen.
Gemcitabine
Gemcitabine at the protocol-defined dose and regimen.
Cisplatin
Cisplatin at the protocol-defined dose and regimen.
Paclitaxel
Paclitaxel at the protocol-defined dose and regimen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Lance Leopold, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Countries
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References
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Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-002904-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 01158-203
Identifier Type: -
Identifier Source: org_study_id
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