A Study of TRK-950 in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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The main purpose of this study is to determine the safety and tolerability of TRK-950 in patients with advanced solid tumors.

Detailed Description
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This is an open-label phase I study of TRK-950 in patients with histologically and cytologically confirmed, metastatic or unresectable solid tumors who are refractory or intolerant to standard therapy or for whom no standard therapy exists. 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.

Official Title
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A Phase I Study of TRK-950 in Patients With Advanced Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Biological: TRK-950


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm : TRK-950<br>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. | Biological: TRK-950<br>* Intravenously over 60 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with dose-limiting toxicities (DLTs) | Number of participants with DLTs will be determined. | Up to Day 28 | 
| Number of participants with adverse events (AEs) | Number of participants with AEs will be assessed. | through study completion, an average of 1 year | 
| Number of participants with adverse events of special interest (AESIs) | Number of participants with AESIs will be assessed. | through study completion, an average of 1 year | 
| Number of participants with serious adverse events (SAEs) | Number of participants with SAEs will be assessed. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration curve (AUC) |  | through study completion, an average of 1 year | 
| Maximum plasma concentration (Cmax) |  | through study completion, an average of 1 year | 
| Time to maximum plasma concentration (Tmax) |  | through study completion, an average of 1 year | 
| Terminal elimination half life (t1/2) |  | through study completion, an average of 1 year | 
| Total body clearance (CL) |  | through study completion, an average of 1 year | 
| Apparent volume of distribution (Vd) |  | through study completion, an average of 1 year |