NL-OMON48697
Withdrawn
Not Applicable
Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Arginase Inhibitor INCB001158 (formerly known as CB-1158) as a Single Agent and in Combination with Immune Checkpoint Therapy in Patients with Advanced/Metastatic Solid Tumors - Incyte INCB 01158-101
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Incyte Corporation
- Enrollment
- 12
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \* 18 years
- •2\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\-1
- •3\. Adequate organ function as indicated by the laboratory values in
- •\* Absolute neutrophil count (ANC) \*1\.500/mcL
- •\* Platelets \* 100,000 / mcL
- •\* Hemoglobin \* 9 g/dL (5,59 mmol/l)
- •\* Creatinine Clearance \* 50 mL/min (calculated using the formula of Cockcroft and Gault)
- •\* Serum total bilirubin OR Direct bilirubin (for patients with Gilbert Syndrome and total bilirubin levels \>1\.5 ULN) \* 1\.5 X ULN OR \* ULN
- •\* AST (SGOT) and ALT (SGPT) \* 2\.5 X ULN
- •\* International Normalized Ratio (INR) or Prothrombin Time (PT) \* 1\.5 X ULN\- Does not apply to patients receiving therapeutic anticoagulation
Exclusion Criteria
- •1\. Any other current or previous malignancy within the past three years except a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, c) prostate cancer with stable prostate specific antigen (PSA) levels for 3 years, d) or other neoplasm that, in the opinion of the Principal Investigator and with the agreement of the Medical Monitor, will not interfere with study\-specific endpoints.
- •2\. Cytotoxic chemotherapy, tyrosine kinase inhibitor (or other targeted anti\-cancer agent), radiation therapy, or hormonal therapy within 14 days or 5 half\-lives, whichever is longer, prior to Cycle 1 Day 1 (42 days for nitrosoureas or mitomycin C).
- •3\. Immunotherapy or biological therapy (e.g., monoclonal antibodies) within 21 days prior to Cycle 1 Day 1
- •\* EXCEPTION: Washout of anti\-PD\-1 therapy is NOT required in the Part 3 Expansion Cohorts.
- •4\. Treatment with an unapproved investigational therapeutic agent within 21 days (or 5 half\-lives for small molecule agents) prior to Cycle 1 Day 1
- •\* EXCEPTION: Washout of anti\-PD\-1 therapy is NOT required in the Part 3 Expansion Cohorts.
- •5\. Has a diagnosis of immunodeficiency or any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other systemic immunosuppressive medications within 14 days prior to the first dose of study treatment. Inhaled steroids and adrenal replacement steroid doses \< 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.;Disease\-specific Exclusion Criteria:;For Part 3:
- •1\. Intolerance to prior anti\-PD\-1/PD\-L1 therapy including 1\) discontinuation due to immune\-related toxicity or, 2\) immune\-related toxicities that that required intensive or prolonged immunosuppression (including, high\-dose IV corticosteroids, \> 2 mo of immunosuppressive corticosteroids (i.e., equivalent of \>10mg oral prednisone daily) or the addition of potent immunosuppression to corticosteroids (e.g., mycophenolate mofetil/CellCept or infliximab) to manage.
- •2\. Prior severe hypersensitivity (\* Grade 3\) to pembrolizumab and/or any of its excipients or prior severe hypersensitivity reaction to any other monoclonal antibody (mAb).
- •3\. Has a history of (non\-infectious) pneumonitis that required steroids or current pneumonitis.
Outcomes
Primary Outcomes
Not specified
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