A study of TRK-950 in patients with advanced solid tumors
- Conditions
- Solid tumors
- Registration Number
- JPRN-jRCT2031220130
- Lead Sponsor
- Mori Yoshitaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 19
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)
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method