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

Sponsor

NewLink Genetics Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03164603

Collaborator

(none)

Enrollment

Locations

Arm

26.9

Actual Duration (Months)

8.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

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 :

Jun 29, 2017

Actual Primary Completion Date :

Apr 1, 2019

Actual Study Completion Date :

Sep 25, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610
2	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
3	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico	United States	87131

Sponsors and Collaborators

NewLink Genetics Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NewLink Genetics Corporation

ClinicalTrials.gov Identifier:

NCT03164603

Other Study ID Numbers:

NLG8021

First Posted:

May 23, 2017

Last Update Posted:

Jun 4, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jun 4, 2020