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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

Brief 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.

Tracking Information
First Received DateSeptember 9, 2016
Last Changed DateNovember 29, 2018
Start DateSeptember 2016
Anticipated Primary Completion DateSeptember 2019
Primary Outcome Measures

Safety and Tolerability of INCB001158 as a single agent and in combination with Pembrolizumab: Incidence of Adverse Events [Time Frame: 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 Measures

Recommended Phase 2 Dose (RP2D) of INCB001158 [Time Frame: 12 Weeks]

RP2D of INCB001158 with Pembrolizumab [Time Frame: 12 Weeks]

Plasma pharmacokinetic (PK) profile of INCB001158 alone and in combination with Pembrolizumab [Time Frame: 12 Weeks]

Anti-tumor Activity of INCB001158 as Monotherapy and in Combination with Pembrolizumab for patients with advanced/metastatic solid tumors [Time Frame: Until disease progression/study discontinuation up to 24 months]

Descriptive Information
PhasePhase 1/Phase 2
Study TypeInterventional
  • Metastatic Cancer
  • Solid Tumors
  • Colorectal Cancer (CRC)
  • Gastric Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Renal Cell Carcinoma (RCC)
  • Bladder Cancer
  • UC (Urothelial Cancer)
  • Mesothelioma
  • Drug: INCB001158
  • Drug: Pembrolizumab
Study Arms / Comparison Groups14 / 0
Detailed Description

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.

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment424
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Incyte Corporation Call Center (US)
Phone: 1.855.463.3463
Eligibility Criteria

*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, 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 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 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 autoimmune disease

- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other systemic immunosuppressive medications within 2 weeks

- Concomitant therapy with valproic acid/valproate-containing therapies

- Concomitant therapy with allopurinol and other xanthine oxidase inhibitors

- History of known risks factors for bowel perforation

- Symptomatic ascites or pleural effusion

- Major surgery within 28 days before Cycle 1 Day 1

- Active infection requiring within 2 weeks prior to first dose of study drug

- Patients who have HIV, Hepatitis B or C

- Conditions that could interfere with treatment or protocol-related procedures

- Active, non-stable brain metastases or CNS disease

- Known deficiencies or suspected defect in the urea cycle

- Received live-virus vaccination within 30 days (seasonal flu vaccine allowed if non-live virus)

- NSCLC with EGFR or ALK mutation

Administrative Information
Responsible PartySponsor
SponsorIncyte Corporation
Verification DateNovember 2018
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