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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/29/2018
Start Date:June 29, 2017
End Date:October 2018
Contact:Eugene Kennedy, MD
Email:clinicaltrials@linkp.com
Phone:515-598-2935

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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 (IDO1) 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
We found this trial at
2
sites
Albuquerque, New Mexico 87131
Principal Investigator: Olivier Rixe, MD
Phone: 505-272-0912
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Thomas George, MD
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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