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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NLG8021 Dose Escalation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NLG802 | Drug | Indoleamine 2,3-Dioxygenase (IDO) Inhibitor |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| Washington University School of Medicine |
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| Percentage of Participants With Progression Free Survival (PFS) | equals date of progression/death - date of study enrollment | 18 months |
| St Louis |
| Missouri |
| 63110 |
| United States |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | United States |