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

Purpose

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.

Criteria

Inclusion Criteria:

  • 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

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
  • Prior malignancy or therapy for a malignancy within 3 years

Gender

N/A

Monetary compensation

No

Can be done from home

No

Keywords

solid tumor, advanced cancer, cancer

Principal Investigator

Thomas J George, M.D.

Department

MD-HEMATOLOGY/ONCOLOGY

Contact Information

tgeorge@ufl.edu

352-273-8008

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