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

Solid Tumor Clinical Trial

Official title:

A Phase 1 Study of NLG802 for Adult Patients With Recurrent Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164603
• Other study ID #: NLG8021
• Status: Completed
• Phase: Phase 1
• Start date: June 29, 2017
• Est. completion date: September 25, 2019

Study information

• Verified date: June 2020
• Source: Lumos Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 25, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• NLG802
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor

Locations

Country	Name	City	State
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico
United States	University of Florida	Gainesville	Florida
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
NewLink Genetics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with dose-limiting toxicities		28 Days
Primary	Percentage of patients with adverse events		From Screening until 30 days after last dose (up to approximately 2 years)
Secondary	Pharmacokinetics: Serum concentrations (Cmax/Steady State)		21 Days
Secondary	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)
Secondary	Percentage of Participants With Progression Free Survival (PFS)	equals date of progression/death - date of study enrollment	18 months