Brief Title
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
Official Title
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
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Phase 1: Participants with treatment-emergent adverse events (TEAE)
Secondary Outcome
Phase 2: Participants with TEAEs
Condition
Biliary Tract Cancer (BTC)
Intervention
INCB001158
Study Arms / Comparison Groups
Treatment Group A
Description: INCB001158 + FOLFOX
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
149
Start Date
November 21, 2017
Completion Date
November 28, 2022
Primary Completion Date
November 28, 2022
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lance Leopold, MD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT03314935
Organization ID
INCB 01158-203
Responsible Party
Sponsor
Study Sponsor
Incyte Corporation
Study Sponsor
Lance Leopold, MD, Study Director, Incyte Corporation
Verification Date
December 2022