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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: NLG802

• Registration Number: NCT03164603
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-23
• Study Start: 2017-06-29
• Primary Completion: 2019-04-01
• Study Completion: 2019-09-25
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NLG8021 Dose Escalation	NLG802	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	equals date of progression/death - date of study enrollment

Trial Locations

Locations (3)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University of New Mexico Comprehensive Cancer Center; 🇺🇸 Albuquerque, New Mexico, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States