Clinical trial · Interventional
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
NCT03164603CI-TRIAL-00045399completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NLG802 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NLG8021 Dose Escalation
- 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.
- interventionNames
- Drug: NLG802
Primary outcomes (2)
- measure
- Percentage of patients with dose-limiting toxicities
- timeFrame
- 28 Days
- measure
- Percentage of patients with adverse events
- timeFrame
- From Screening until 30 days after last dose (up to approximately 2 years)
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.