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

NCT03164603 | Completed Phase 1 FDA Drug

• 1 other identifier: NLG8021
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with dose-limiting toxicities

  28 Days

• Percentage of patients with adverse events

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

Secondary Outcomes (3)

• Pharmacokinetics: Serum concentrations (Cmax/Steady State)

  21 Days

• 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

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

• Percentage of Participants With Progression Free Survival (PFS)

  18 months

Study Arms (1)

NLG8021 Dose Escalation

EXPERIMENTAL

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

Interventions

NLG802 DRUG

Indoleamine 2,3-Dioxygenase (IDO) Inhibitor

NLG8021 Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NewLink Genetics Corporation: lead

Study Sites (3)

University of Florida

Gainesville, Florida, 32610, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 23, 2017
• Study Start: June 29, 2017
• Primary Completion: April 1, 2019
• Study Completion: September 25, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)