Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy… (NCT02903914) | Clinical Trial Compass
CompletedPhase 1
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
United States260 participantsStarted 2016-09-14
Plain-language summary
This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.
Who can participate
Age range18 Years
SexALL
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\*Additional cohort specific criteria may apply
Inclusion Criteria:
* Must be age 18 or older
* Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
* Histological or cytological diagnosis of metastatic cancer or locally advanced cancer that is not amenable to local therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Life Expectancy of at least 3 months
* Adequate hepatic, renal (moderately impaired renal function in cohort 1c only), cardiac, and hematologic function
* Measurable disease by RECISTv1.1 criteria
* Resolution of treatment-related toxicities
* Willingness to avoid pregnancy or fathering children
* Prior anti-PD-1 treatment for combination dose expansion cohorts 1c, 3a - 3d
Exclusion Criteria:
* Currently pregnant or lactating
* Unable to receive oral medications
* Unable to receive oral or IV hydration
* Intolerance to prior anti-PD-1/PD-L1 therapy
* Prior anti-PD-1 treatment for combination dose expansion cohorts 1c, 3e - 3h
* Prior severe hypersensitivity reaction to another monoclonal antibody (mAb)
* Any other current or previous malignancy within 3 years except protocol allowed malignancies
* Chemotherapy, Tyrosine Kinase Inhibitor therapy, radiation therapy or hormonal therapy within 2 weeks
* Immunotherapy or biological therapy, or investigational agent within 3 weeks (Note: some cohort exceptions allow anti-PD-1 therapy)
* Active known or suspected exclusionary autoimmu…
What they're measuring
1
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Timeframe: up to study completion (up to approximately 3.5 years)