Protocol Summary

Protocol No.: OCR16937

Sponsor Protocol No.: NLG-8021

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

Principal Investigator(s)
George, Thomas

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

Scope: National

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
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

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 Disease Sites
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
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Skin Cancer
Urologic Cancer

Participating Institutions
UF Gainesville : Marlene Sarmiento

Marlene Sarmiento, RN
Phone: +1 352-265-0680 ext. 50704


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