A Study of TRK-950 in Patients With Advanced Solid Tumors
- Conditions
- Solid Tumor
- Registration Number
- NCT05423262
- Lead Sponsor
- Toray Industries, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Part 1: Patients with histologically and cytologically confirmed locally advanced or<br> metastatic solid tumors who have been refractory or intolerant to standard therapies<br> or for whom no standard therapy exists. Part 2: Patients with histologically and<br> cytologically confirmed locally advanced or metastatic solid tumors who are eligible<br> for standard therapy with NIVO 240 mg alone administered at 2-week intervals.<br><br> - Patients with life expectancy of at least 3 months after the start of study drug<br> administration<br><br> - Patients aged >=18 years at the time of consent<br><br> - Patients who are able to provide written consent in person to be a subject of this<br> study<br><br> - A negative pregnancy test before enrollment (if female of childbearing potential)<br><br>Exclusion Criteria:<br><br> - Patients with active, uncontrolled bacterial, viral, or fungal infection requiring<br> systemic therapy<br><br> - Pregnant women (including those who are considered possibly pregnant based on<br> history taking, etc. by physician) or breastfeeding women (interrupting<br> breastfeeding to enroll is also not allowed)<br><br> - Patients who are unwilling or unable to comply with the protocol specified<br> procedures<br><br> - Patients who are positive for human immunodeficiency virus (HIV) antibody<br><br> - Patients who meet any of the following conditions on hepatitis B virus (HBV) and<br> hepatitis C virus (HCV) testing<br><br> - Patients who are positive for hepatitis B surface antigen (HBsAg)<br><br> - Patients who are positive for HCV RNA
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with dose-limiting toxicities (DLTs);Number of participants with adverse events (AEs);Number of participants with adverse events of special interest (AESIs);Number of participants with serious adverse events (SAEs)
- Secondary Outcome Measures
Name Time Method Area under the concentration curve (AUC) of TRK-950;Maximum plasma concentration (Cmax) of TRK-950;Time to maximum plasma concentration (Tmax) of TRK-950;Terminal elimination half life (t1/2) of TRK-950;Total body clearance (CL) of TRK-950;Apparent volume of distribution (Vd) of TRK-950;Area under the concentration curve (AUC) of Nivolumab (Part 2 only)