A Multicenter, Open-Label, Phase I Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulation in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant
研究概览
简要总结
A Multicenter, Open-Label, Phase I Clinical Study to assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulation in Participants with Advanced Solid Tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available.
- •At least 4 weeks since any previous treatment for cancer
- •Subject must consent to pretreatment and on treatment tumor biopsies
- •Adequate organ and marrow function
排除标准
- •Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
- •Participants with second/other active cancers requiring current treatment
- •Uncontrolled/significant heart disease
- •Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or - - Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
- •Active/uncontrolled autoimmune disease
- •Active infection Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Inupadenant sequential dose escalation (Part 1A)
Part 1A will evaluate the safety as well as to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of inupadenant in participants with advanced solid tumors.
干预措施: Inupadenant (Drug)
Inupadenant randomized crossover (Part 1B)
The effect of food on the exposure to inupadenant will be investigated in participants with advanced solid tumors.
干预措施: Inupadenant (Drug)
Inupadenant single treatment assignment (Part 1C)
Part 1C will investigate an additional formulation of inupadenant in participants with advanced solid tumors.
干预措施: Inupadenant (Drug)
结局指标
主要结局
Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant
时间窗: During the DLT evaluation period that is cycle 1 (each cycle is 4 weeks)
Incidence of adverse events (AEs), serious adverse events (SAEs), DLTs, AEs leading to discontinuation, deaths, electrocardiogram (ECG) abnormalities, and clinically significant laboratory abnormalities
Incidence and severity of AEs in patients receiving inupadenant
时间窗: Through study completion, an average of 4 months
To assess safety and tolerability as measured by incidence and severity of AEs
次要结局
- Plasma concentration of inupadenant vs. time profiles(Through study completion, an average of 4 months)
- Maximum observed serum concentration (Cmax)(Through study completion, an average of 4 months)
- Time of maximum observed concentration (Tmax)(Through study completion, an average of 4 months)
- Area under the concentration-time curve in 1 dosing interval [AUC(TAU)](Through study completion, an average of 4 months)
- Plasma concentration half-life (T-HALF)(Through study completion, an average of 4 months)
- Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1(Through study completion, an average of 4 months)