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

A Phase 1 Study of NLG802 for Adult Patients With Recurrent Advanced Solid Tumors

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.

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