Protocol Summary

Protocol No.: OCR16937

Sponsor Protocol No.: NLG-8021

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

Principal Investigator: George, Thomas

Objective: 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 I

Age Group: Adult

Age: 18 Years - N/A

Gender: All

Scope: National

Treatment:
NLG8021 Dose Escalation
Approximately 6 to 36 participants will be enrolled and treated at escalating doses of NLG802. Treatment may continue until unacceptable toxicity or disease progression. Successive groups of at least 3 participants will be evaluated during a 28-day window for DLTs, which will determine the enrollment and dosing for subsequent cohorts in the dose-escalation stage.

Detailed Eligibility:
INCLUSION CRITERIA:
1. 18 years old and older
2. Histologically or cytologically confirmed solid tumor cancer
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Adequate hematologic and organ function
5. Negative pregnancy test and willingness to utilize contraception among women of childbearing potential
6. Life expectancy at least 4 months
EXCLUSION CRITERIA:
1. Active or history of medically significant autoimmune disease
2. Cytotoxic therapy or investigational agent use within 28 days
3. Human immunodeficiency virus (HIV), active hepatitis B or C
4. Untreated brain metastases
5. Known QT interval prolongation
6. Use of concomitant medications with high risk of causing Torsades des Pointes.
7. Use of immune suppressive agents within 30 days
8. Prior malignancy or therapy for a malignancy within 3 years

Applicable Conditions:

  • Bladder Cancer
  • Brain and Nervous System
  • Breast Cancer
  • Colon Cancer
  • Gastrointestinal Cancer
  • Gynecologic Cancer
  • Head & Neck Cancer
  • Kidney Cancer (Renal Cell)
  • Liver Cancer
  • Lung Cancer
  • Melanoma
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Sarcoma
  • Skin Cancer
  • Urologic Cancer
  • Participation Institution:

  • UF Gainesville : Marlene Sarmiento
  • Contact:
    Marlene Sarmiento, RN
    Phone: +1 352-265-0680 ext. 50704
    Email: msarmien@ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03164603