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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05423262
Study type Interventional
Source Toray Industries, Inc
Contact Toray Contact for Clinical Trial Information
Phone +81467-32-9948
Email npdd-clinical.toray.mb@mail.toray
Status Recruiting
Phase Phase 1
Start date July 6, 2022
Completion date February 2025

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