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

Study Overview
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Brief Summary
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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.

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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: NLG802


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NLG8021 Dose Escalation<br>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<br>* Indoleamine 2,3-Dioxygenase (IDO) Inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | equals date of progression/death - date of study enrollment | 18 months |