At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 260 enrolled
Drug / intervention
INCB001158 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Arginase Inhibitor INCB001158 (Formerly Known as CB1158) as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
In Brief
A Phase 1 clinical trial evaluating INCB001158 and Pembrolizumab for Metastatic Cancer and 9 related conditions. Completed, enrolled 260 participants across 20 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Cancer, Solid Tumors, Colorectal Cancer (CRC), Gastric Cancer, Head and Neck Cancer, Lung Cancer, Renal Cell Carcinoma (RCC), Bladder Cancer, UC (Urothelial Cancer), Mesothelioma
CountriesItaly, Netherlands, Spain, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartSep 2016
First PostedSep 2016
Primary CompletionApr 2020
Study CompletionAug 2022
TodayJul 2026
First PostedSep 16, 2016
Enrollment StartSep 14, 2016
Primary CompletionApr 30, 2020
Study CompletionAug 15, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.8 years ago
Interventions
INCB001158drug
Arginase Inhibitor
Pembrolizumabdrug
PD-1 Inhibitor