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

    Not Recruiting
  • participants needed
  • sponsor
    Incyte Corporation
Updated on 2 August 2021
Incyte Corporation Call Center
Primary Contact
BIDMC (4.5 mi away) Contact
+18 other location
renal function
measurable disease
solid tumour
solid neoplasm
renal function test
kidney function test
impaired renal function


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.


This study is an open-label Phase 1 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.

Single Agent INCB001158:

Patients with advanced/metastatic solid tumors will be enrolled into escalating monotherapy dose cohorts to determine the Recommended Phase 2 Dose (RP2D) of INCB001158. Additional patients with NSCLC, Colorectal Cancer (CRC), and other tumors including SCCHN, RCC, Gastric, Bladder and Melanoma will be enrolled at the single agent RP2D.

Combination Treatment:

Patients with advanced/metastatic NSCLC, Melanoma, Urothelial, Microsatellite Instability (MSI)/ Microsatellite Stable (MSS) CRC, Gastric, SCCHN and Mesothelioma will be enrolled into separate cohorts of combination therapy (INCB001158 and Pembrolizumab) to determine the RP2D.

In the dose expansion phase, additional patients with NSCLC, Melanoma, Urothelial, MSI/MSS CRC, Gastric, SCCHN and Mesothelioma will be treated with the combination of INCB001158 and Pembrolizumab at the RP2D.

All patients will be assessed for safety, pharmacokinetics, biomarkers and tumor response.

Condition Non-Small Cell Lung Cancer, Pulmonary Disease, Adenocarcinoma, urinary tract neoplasm, Colorectal Cancer, Malignant neoplasm of kidney, Rectal disorder, Metastasis, bladder cancer, bladder disorder, Transitional cell carcinoma, Renal Cell Carcinoma, Lung Neoplasm, Ulcerative Colitis, Mesothelioma, Gastropathy, Gastric Cancer, Bronchial Neoplasm, Mesothelioma, head and neck cancer, Stomach Discomfort, Liver Metastases, Bone Metastases, Colon Cancer Screening, Rectal Disorders, Solid Tumors, Colon cancer; rectal cancer, Squamous Cell Carcinoma of the Head and Neck, Brain Metastases, Urothelial Cancer, Ulcerative Colitis (Pediatric), Kidney Cancer, Lung Cancer, Malignant Adenoma, Lung Disease, Stomach Cancer, Metastatic Cancer, Bladder Disorders, Renal Cell Cancer, Renal Cancer, Neoplasm Metastasis, Bladder Carcinoma, Urologic Cancer, Urothelial Carcinoma, UC
Treatment Pembrolizumab, Nivolumab, CB-1158, INCB001158
Clinical Study IdentifierNCT02903914
SponsorIncyte Corporation
Last Modified on2 August 2021

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