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Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors

NCT02903914 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-08-05

Study results available
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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.

Conditions

Interventions

DRUG

INCB001158

Arginase Inhibitor

DRUG

Pembrolizumab

PD-1 Inhibitor

Sponsors & Collaborators

Principal Investigators

  • Emil Kuriakose, MD · Calithera Biosciences, Inc

  • Sven Gogov, MD · Incyte Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-14
Primary Completion
2020-04-30
Completion
2022-08-15
FDA Drug
Yes

Countries

  • United States
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903914 on ClinicalTrials.gov