NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.

Key facts

Study ID

NCT03164603

Run by

NewLink Genetics Corporation

People needed

26

Starts

2017-06-29

Expected to finish

2019-09-25

Last updated by the study team

2020-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed solid tumor cancer (including glioblastoma)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematologic and organ function

You may not qualify if…

• Active or history of medically significant autoimmune disease
• Cytotoxic therapy or investigational agent use within 28 days
• Human immunodeficiency virus (HIV), active hepatitis B or C
• Untreated brain metastases
• Known QT interval prolongation
• Use of concomitant medications with high risk of causing Torsades des Pointes.
• Use of immune suppressive agents within 30 days
• More than one active malignancy at the time of enrollment

Where it is running

• University of Florida — Gainesville, Florida, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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