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

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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Biological: TRK-950; Biological: TRK-950; Biological: TRK-950; Drug: Nivolumab

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 19
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Toray Contact for Clinical Trial Information; Phone Number: +81467-32-9948; Email: npdd-clinical.toray.mb@mail.toray

Study Locations

• Japan
  • Tokyo
    • Chuo Ku, Tokyo, Japan
      • Recruiting
      • National Cancer Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 : TRK-950; Solid Tumor; TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle. Two dose levels will be explored during this Arm.	Biological: TRK-950; 10 mg/kg administered intravenously over 60 minutes (weekly); Biological: TRK-950; 5 or 10 mg/kg administered intravenously over 60 minutes (weekly); Biological: TRK-950; 20 mg/kg administered intravenously over 60 minutes (bi-weekly)
Experimental: Part 2 Cohort 1: TRK-950+Nivolumab; Nivolumab-eligible solid tumor; Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1, 8, 15 and 22. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.	Biological: TRK-950; 10 mg/kg administered intravenously over 60 minutes (weekly); Biological: TRK-950; 5 or 10 mg/kg administered intravenously over 60 minutes (weekly); Biological: TRK-950; 20 mg/kg administered intravenously over 60 minutes (bi-weekly); Drug: Nivolumab; 240 mg administered intravenously over 30 minutes (bi-weekly)
Experimental: Part 2 Cohort 2: TRK-950+Nivolumab; Nivolumab-eligible solid tumor; Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1 and 15. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.	Biological: TRK-950; 10 mg/kg administered intravenously over 60 minutes (weekly); Biological: TRK-950; 5 or 10 mg/kg administered intravenously over 60 minutes (weekly); Biological: TRK-950; 20 mg/kg administered intravenously over 60 minutes (bi-weekly); Drug: Nivolumab; 240 mg administered intravenously over 30 minutes (bi-weekly)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with dose-limiting toxicities (DLTs)	Number of participants with DLTs will be determined.	Up to Day 28
Number of participants with adverse events (AEs)	Number of participants with AEs will be assessed.	through study completion, an average of 1 year
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
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 Outcome Measures

Outcome Measure	Time Frame
Area under the concentration curve (AUC) of TRK-950	through study completion, an average of 1 year
Maximum plasma concentration (Cmax) of TRK-950	through study completion, an average of 1 year
Time to maximum plasma concentration (Tmax) of TRK-950	through study completion, an average of 1 year
Terminal elimination half life (t1/2) of TRK-950	through study completion, an average of 1 year
Total body clearance (CL) of TRK-950	through study completion, an average of 1 year
Apparent volume of distribution (Vd) of TRK-950	through study completion, an average of 1 year
Area under the concentration curve (AUC) of Nivolumab (Part 2 only)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Toray Industries, Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Nivolumab-eligible solid tumor
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: 950P1V03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No