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

NewLink Genetics

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Drug: NLG802

Study type: Interventional

Funder types: Industry

Identifiers

NCT03164603

NLG8021

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

NLG8021 Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: NLG802