A Study of TRK-950 in Patients with Advanced Solid Tumors
- Registration Number
- NCT05423262
- Lead Sponsor
- Toray Industries, Inc
- Brief Summary
The main purpose of this study is to determine the safety and tolerability of TRK-950 alone and in combination with Nivolumab in patients with advanced solid tumors
- Detailed Description
This is an open-label phase I study and consists of two parts. In the 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 the Part 2, patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with Nivolumab 240 mg alone administered at 2-week intervals will receive two dose level of TRK-950 in combination with Nivolumab. 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 13
- 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.
- 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)
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Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
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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)
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Patients who are unwilling or unable to comply with the protocol specified procedures
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Patients who are positive for human immunodeficiency virus (HIV) antibody
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1 : TRK-950 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. Part 2 Cohort 1: TRK-950+Nivolumab TRK-950 * 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. Part 2 Cohort 2: TRK-950+Nivolumab TRK-950 * 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. Part 2 Cohort 2: TRK-950+Nivolumab 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. Part 2 Cohort 1: TRK-950+Nivolumab 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.
- Primary Outcome Measures
Name Time Method Number of participants with dose-limiting toxicities (DLTs) Up to Day 28 Number of participants with DLTs will be determined.
Number of participants with serious adverse events (SAEs) through study completion, an average of 1 year Number of participants with SAEs will be assessed.
Number of participants with adverse events (AEs) 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) through study completion, an average of 1 year Number of participants with AESIs will be assessed.
- Secondary Outcome Measures
Name Time Method 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 through study completion, an average of 1 year Maximum plasma concentration (Cmax) of TRK-950 through study completion, an average of 1 year Time to maximum plasma concentration (Tmax) of TRK-950 through study completion, an average of 1 year Terminal elimination half life (t1/2) of TRK-950 through study completion, an average of 1 year Total body clearance (CL) of TRK-950 through study completion, an average of 1 year Apparent volume of distribution (Vd) of TRK-950 through study completion, an average of 1 year
Trial Locations
- Locations (1)
National Cancer Center Hospital
🇯🇵Chuo Ku, Tokyo, Japan