NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors
NCT ID: NCT03164603
Last Updated: 2020-06-04
Study Results
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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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2017-06-29
2019-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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.
NLG802
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor
Interventions
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NLG802
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic and organ function
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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NewLink Genetics Corporation
INDUSTRY
Responsible Party
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Locations
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University of Florida
Gainesville, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Countries
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Other Identifiers
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NLG8021
Identifier Type: -
Identifier Source: org_study_id
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