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

NCT ID: NCT03164603

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-29

Study Completion Date

2019-09-25

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

NLG802

Intervention Type DRUG

Indoleamine 2,3-Dioxygenase (IDO) Inhibitor

Interventions

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NLG802

Indoleamine 2,3-Dioxygenase (IDO) Inhibitor

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NewLink Genetics Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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NLG8021

Identifier Type: -

Identifier Source: org_study_id

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