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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05423262
• Other study ID #: 950P1V03
• Status: Recruiting
• Phase: Phase 1
• Start date: July 6, 2022
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Toray Industries, Inc
• Contact: Toray Contact for Clinical Trial Information
• Phone: +81467-32-9948
• Email: npdd-clinical.toray.mb[@]mail.toray
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• TRK-950
5 or 10 mg/kg administered intravenously over 60 minutes (weekly)
• TRK-950
10 mg/kg administered intravenously over 60 minutes (weekly)
• TRK-950
20 mg/kg administered intravenously over 60 minutes (bi-weekly)

Drug:
• Nivolumab
240 mg administered intravenously over 30 minutes (bi-weekly)

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Toray Industries, Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with dose-limiting toxicities (DLTs)	Number of participants with DLTs will be determined.	Up to Day 28
Primary	Number of participants with adverse events (AEs)	Number of participants with AEs will be assessed.	through study completion, an average of 1 year
Primary	Number of participants with adverse events of special interest (AESIs)	Number of participants with AESIs will be assessed.	through study completion, an average of 1 year
Primary	Number of participants with serious adverse events (SAEs)	Number of participants with SAEs will be assessed.	through study completion, an average of 1 year
Secondary	Area under the concentration curve (AUC) of TRK-950		through study completion, an average of 1 year
Secondary	Maximum plasma concentration (Cmax) of TRK-950		through study completion, an average of 1 year
Secondary	Time to maximum plasma concentration (Tmax) of TRK-950		through study completion, an average of 1 year
Secondary	Terminal elimination half life (t1/2) of TRK-950		through study completion, an average of 1 year
Secondary	Total body clearance (CL) of TRK-950		through study completion, an average of 1 year
Secondary	Apparent volume of distribution (Vd) of TRK-950		through study completion, an average of 1 year
Secondary	Area under the concentration curve (AUC) of Nivolumab (Part 2 only)		through study completion, an average of 1 year