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

• Status: Completed
• Trial end date: 2019-09-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: NewLink Genetics Corporation

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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