Advanced/Metastatic, Colorectal Cancer, Stomach or Esophageal Cancer, Head and Neck Cancer, Small Cell Lung Cancer, Kidney Cancer, Bladder Cancer, Mesothelioma
Arginase Inhibitor INCB001158 as a Single Agent and in Combination with Immune Checkpoint Therapy in Patients with Advanced/Metastatic Solid tumors
Incyte Study ID:
INCB 01158-101
CT.gov ID:
Eudra ID:
Sponsor:
Incyte
Collaborator:
N/A
Study Contact Information:
Results Available
Protocol
Available Languages: English
Statistical Analysis Plan (SAP)
Available Languages: English
Clinical Study Purpose
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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Sep 2016 - Aug 2020
TYPE
Interventional
PHASE
Phase 1/Phase 2
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Name
Contact UsName
University of South Alabama
Mobile, Alabama, US, 36604
Name
Honor Health/Pinnacle Oncology Hematology
Scottsdale, Arizona, US, 85258
Name
University of Arizona
Tucson, Arizona, US, 85719
Name
Georgetown
Washington, District of Columbia, US, 20007
Name
Johns Hopkins
Baltimore, Maryland, US, 21287
Name
DFCI
Boston, Massachusetts, US, 02215
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Must be age 18 or older
- Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
Exclusion Criteria
- Currently pregnant or lactating
- Unable to receive oral medications
Protocol Summary
Incyte Study ID:
INCB 01158-101
Primary Purpose:
Treatment
Allocation:
Non-randomized
Study Design:
Factorial Assignment
Masking:
None (Open Label)
Interventions:
Drug
Enrollment:
260
Primary Outcome
Open
Safety and Tolerability of INCB001158 as a single agent and in combination with Pembrolizumab: Incidence of Adverse Events
Timeframe: Every 28 days (single agent INCB001158) or 21 days (INCB001158 in combination with Pembrolizumab) from study start until disease progression or unacceptable toxicity, assessed for an expected average of 6 months
Secondary Outcome
Open
Recommended Phase 2 Dose (RP2D) of INCB001158
Timeframe: 12 Weeks
RP2D of INCB001158 with Pembrolizumab
Timeframe: 12 Weeks
Plasma pharmacokinetic (PK) profile of INCB001158 alone and in combination with Pembrolizumab
Timeframe: 12 Weeks
Anti-tumor Activity of INCB001158 as Monotherapy and in Combination with Pembrolizumab for patients with advanced/metastatic solid tumors
Timeframe: Until disease progression/study discontinuation up to 24 months