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

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Toray Industries, Inc
• Treatments: Nivolumab

Criteria

Inclusion Criteria:

• 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)

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