A Phase 1 Study of NLG802 for Adult Patients With Recurrent Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Percentage of patients with dose-limiting toxicities
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NLG8021 Dose Escalation
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.
干预措施: NLG802 (Drug)
结局指标
主要结局
Percentage of patients with dose-limiting toxicities
时间窗: 28 Days
Percentage of patients with adverse events
时间窗: From Screening until 30 days after last dose (up to approximately 2 years)
次要结局
- 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)