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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03164603

Enrollment

Registered

2017-05-23

Start date

2017-06-29

Completion date

2019-09-25

Last updated

2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

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.

Interventions

DRUGNLG802

Indoleamine 2,3-Dioxygenase (IDO) Inhibitor

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026