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.


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



Monetary compensation


Can be done from home



solid tumor, advanced cancer, cancer

Principal Investigator

Thomas J George, M.D.



Contact Information



Be an Informed Participant

Before deciding to participate in a research study, take time to learn about clinical research, how it's conducted and your rights as a research participant. Following are some helpful resources from independent sources. Always remember that a clinical research study is research, not treatment.

Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
  • Your Rights: For questions about your rights as a research participant, contact the UF Institutional Review Boards at 352-273-9600.
  • Feedback: For general questions or feedback about study listings, email the UF Clinical and Translational Science Institute at UFStudies@health.ufl.edu.

Other Resources

  • HealthStreet: Health-focused services, classes and events, and opportunities to participate in research.
  • ResearchMatch.org: Join a national registry of volunteers willing to be contacted about research studies.

For Research Teams