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Completed

NCT Number: NCT03164603

NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in 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.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Florida, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed solid tumor cancer (including glioblastoma)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic and organ function

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
  • More than one active malignancy at the time of enrollment

Treatment and study plan

NLG802

Drug

Indoleamine 2,3-Dioxygenase (IDO) Inhibitor

Primary outcomes

  1. Percentage of patients with dose-limiting toxicities

    Time frame: 28 Days

  2. Percentage of patients with adverse events

    Time frame: From Screening until 30 days after last dose (up to approximately 2 years)

Secondary outcomes

  1. Pharmacokinetics: Serum concentrations (Cmax/Steady State)

    Time frame: 21 Days

  2. Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Determined by the Investigator

    Time frame: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)

  3. Percentage of Participants With Progression Free Survival (PFS)

    Time frame: 18 months

    equals date of progression/death - date of study enrollment

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Sponsors and collaborators

Lead sponsor

NewLink Genetics Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 23, 2017
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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