A study of TRK-950 in patients with advanced solid tumors

JRCT ID: jRCT2031220130

Registered date:11/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solid tumors
• Date of first enrollment: 06/07/2022
• Target sample size: 19
• Study type: Interventional

Intervention(s)

Part 1
- Investigational material: TRK-950
5 or 10 mg/kg administered Intravenously over 60 minutes (weekly)

Part 2 Cohort 1
- Investigational material: TRK-950
10 mg/kg administered Intravenously over 60 minutes (weekly)
- Concomitant material: Nivolumab
240 mg administered Intravenously over >=30 minutes (bi-weekly)

Part 2 Cohort 2
- Investigational material: TRK-950
20 mg/kg administered Intravenously over 60 minutes (bi-weekly)
- Concomitant material: Nivolumab
240 mg administered Intravenously over >=30 minutes (bi-weekly)

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Mori Yoshitaka
• Secondary ID(s): NCT05423262