A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors.

Incyte Corporation0 sites249 target enrollmentSeptember 27, 2017

DrugsCalcium Folinate Fluorouracil gemcitabine cisplatin paclitaxel

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Incyte Corporation
Enrollment: 249
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 27, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Incyte Corporation

Eligibility Criteria

Inclusion Criteria

•Men or women aged 18 years or older.
•Presence of measurable disease per RECIST v1\.1\. (If subjects have only 1 measurable lesion per RECIST v1\.1, this lesion should not have been in the field of prior irradiation unless there is documented progression of the lesion(s)).
•ECOG performance status 0 to 1\.
•Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or 20 unstained slides from biopsy or resection of primary tumor or metastasis that are \= 2 years old.
•Willingness to undergo pretreatment and on\-treatment tumor biopsies, until at least 5 evaluable paired specimens are collected in each cohort.
•Have resolution of all toxicities and any toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia).
•Adequate renal, hepatic, and hematologic functions as defined by laboratory parameters within \= 7 days before treatment initiation.
•\- Absolute neutrophil count \= 1\.5 × 10^9/L.
•\- Platelets \= 100 × 10^9/L.
•\- Hemoglobin \= 9 g/dL.

Exclusion Criteria

•Participation in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half\-lives (whichever is longer) before first dose. For investigational agents with long half\-lives (eg, 5 days), enrollment before the fifth half\-life requires medical monitor approval.
•Has received a prior monoclonal antibody within 4 weeks or 5 half\-lives (whichever is shorter) before administration of study drug.
•\- Exception: Washout of immune checkpoint inhibitor therapy is NOT required.
•\- Exception: Denosumab may be used.
•Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
•Has received prior approved radiotherapy within 14 days of study therapy (exception for radiation to central nervous system \[CNS], which requires \= 28\-day washout as described below).
•Note: Subjects must have recovered from all radiation\-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1\-week washout is permitted for palliative radiation (\= 2 weeks of radiation therapy) to non\-CNS disease
•Subjects must not have received therapy with an arginase inhibitor.
•Note: Prior immunotherapy treatment with an anti–programmed death\-1 receptor, anti–programmed death\-1 receptor ligand, anti–programmed death\-2 receptor ligand, anti–cytotoxic T\-lymphocyte–associated protein 4, anti\-CD137, or any other antibody or drug specifically targeting immune checkpoint pathways is allowed.
•Has had major surgery within 4 weeks before enrollment (C1D1\).