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

• Status: Active, not recruiting
• Trial end date: 2021-11-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Calithera Biosciences, Inc; Incyte Corporation
• Treatments: Nivolumab; Pembrolizumab

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 (moderately impaired renal function in cohort 1c only), 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 1c, 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 1c, 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