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Trial record 1 of 1 for:    NLG802
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NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03164603
Recruitment Status : Active, not recruiting
First Posted : May 23, 2017
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
NewLink Genetics Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: NLG802 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of NLG802 for Adult Patients With Recurrent Advanced Solid Tumors
Actual Study Start Date : June 29, 2017
Actual Primary Completion Date : April 1, 2019
Estimated Study Completion Date : October 29, 2019

Arm Intervention/treatment
Experimental: 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.
Drug: NLG802
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor




Primary Outcome Measures :
  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 Outcome Measures :
  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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164603


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Mexico
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
NewLink Genetics Corporation

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Responsible Party: NewLink Genetics Corporation
ClinicalTrials.gov Identifier: NCT03164603     History of Changes
Other Study ID Numbers: NLG8021
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No