A Phase I/II Study of TRK-950 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 10
- 主要终点
- Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2)
研究概览
简要总结
Part 1
• To determine the safety and tolerability of TRK-950 in patients with advanced solid tumors
Part 2
• To determine the safety and tolerability of TRK-950 in combination with nivolumab(NIVO) in patients with advanced solid tumors eligible for NIVO therapy
Part 3
• To determine the efficacy of TRK-950 in patients with advanced/recurrent unresectable melanoma, who received prior chemotherapy with dacarbazine(DTIC) and for whom no standard therapy exists
详细描述
This is an open-label phase I/II study and consists of three parts. In Part 1, patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists will receive two dose level of TRK-950. In Part 2, patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with NIVO 240 mg alone administered at 2-week intervals will receive two dose level of TRK-950 in combination with Nivolumab. In Part 3, patients with histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma), who received prior chemotherapy with DTIC and for whom no standard therapy exists will receive one dose level of TRK-950. The objectives of this study are to determine the safety, tolerability, pharmacokinetic (PK) profile and the incidence of the development of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against TRK-950.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Part 1: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists. Part 2: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with NIVO 240 mg alone administered at 2-week intervals.
- •Part 3: Patients with histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma), who received prior chemotherapy with DTIC and for whom no standard therapy exists
- •Patients with life expectancy of at least 3 months after the start of study drug administration
- •Patients aged >=18 years at the time of consent
- •Patients who are able to provide written consent in person to be a subject of this study
- •A negative pregnancy test before enrollment (if female of childbearing potential)
排除标准
- •Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- •Pregnant women (including those who are considered possibly pregnant based on history taking, etc. by physician) or breastfeeding women (interrupting breastfeeding to enroll is also not allowed)
- •Patients who are unwilling or unable to comply with the protocol specified procedures
- •Patients who are positive for human immunodeficiency virus (HIV) antibody
- •Patients who meet any of the following conditions on hepatitis B virus (HBV) and hepatitis C virus (HCV) testing
- •Patients who are positive for hepatitis B surface antigen (HBsAg)
- •Patients who are positive for HCV RNA
研究组 & 干预措施
Part 3: TRK-950
- Melanoma
- TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle.
干预措施: TRK-950 (Biological)
Part 2 Cohort 2: TRK-950+Nivolumab
- Nivolumab-eligible solid tumor
- Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1 and 15. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.
干预措施: Nivolumab (Drug)
Part 1 : TRK-950
- Solid Tumor
- TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle. Two dose levels will be explored during this Arm.
干预措施: TRK-950 (Biological)
Part 2 Cohort 1: TRK-950+Nivolumab
- Nivolumab-eligible solid tumor
- Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1, 8, 15 and 22. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.
干预措施: TRK-950 (Biological)
Part 2 Cohort 1: TRK-950+Nivolumab
- Nivolumab-eligible solid tumor
- Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1, 8, 15 and 22. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.
干预措施: Nivolumab (Drug)
Part 2 Cohort 2: TRK-950+Nivolumab
- Nivolumab-eligible solid tumor
- Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1 and 15. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.
干预措施: TRK-950 (Biological)
结局指标
主要结局
Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2)
时间窗: Up to Day 28
Number of participants with DLTs will be determined.
Number of participants with adverse events (AEs) (Part 1 and 2)
时间窗: through study completion, an average of 1 year
Number of participants with AEs will be assessed.
Number of participants with adverse events of special interest (AESIs) (Part 1 and 2)
时间窗: through study completion, an average of 1 year
Number of participants with AESIs will be assessed.
Number of participants with serious adverse events (SAEs) (Part 1 and 2)
时间窗: through study completion, an average of 1 year
Number of participants with SAEs will be assessed.
Objective response rate (ORR) (Part 3)
时间窗: Up to approximately 12 months
Objective response rate (ORR) is defined as the percentage of patients who achieved either complete response (CR) or partial response (PR) as assessed by independent central review (ICR) per RECIST Version 1.1.
次要结局
- Area under the concentration curve (AUC) of Nivolumab (Part 2 only)(through study completion, an average of 1 year)
- Area under the concentration curve (AUC) of TRK-950 (Part 1 and 2)(through study completion, an average of 1 year)
- Maximum plasma concentration (Cmax) of TRK-950 (Part 1 and 2)(through study completion, an average of 1 year)
- Time to maximum plasma concentration (Tmax) of TRK-950 (Part 1 and 2)(through study completion, an average of 1 year)
- Terminal elimination half life (t1/2) of TRK-950 (Part 1 and 2)(through study completion, an average of 1 year)
- Total body clearance (CL) of TRK-950 (Part 1 and 2)(through study completion, an average of 1 year)
- Duration of response (DOR) (Part 3)(Up to approximately 12 months)
- Tumor change rate (Part 3)(Up to approximately 12 months)
- Apparent volume of distribution (Vd) of TRK-950 (Part 1 and 2)(through study completion, an average of 1 year)
- Area under the concentration curve (AUC) of Nivolumab (Part 2 only)(through study completion, an average of 1 year)
- Overall survival (OS) (Part 3)(Up to approximately 12 months)
- Progression-free survival (PFS) (Part 3)(Up to approximately 12 months)
- Best overall response (BOR) (Part 3)(Up to approximately 12 months)
- Disease control rate (DCR) (Part 3)(Up to approximately 12 months)