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 enzyme and help the human immune system attack solid tumor cells more effectively.
- Histologically or cytologically confirmed solid tumor cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic and organ function
- Negative pregnancy test and willingness to utilize contraception among women of childbearing potential
- Life expectancy at least 4 months
- 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
- Prior malignancy or therapy for a malignancy within 3 years
Can be done from home
Keywordssolid tumor, advanced cancer, cancer
Principal InvestigatorThomas J George, M.D.
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