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

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

Part 1

• To determine the safety and tolerability of TRK-950 in patients with advanced solid tumors

Part 2

• To determine the safety and tolerability of TRK-950 in combination with nivolumab(NIVO) in patients with advanced solid tumors eligible for NIVO therapy

Part 3

• To determine the efficacy of TRK-950 in patients with advanced/recurrent unresectable melanoma, who received prior chemotherapy with dacarbazine(DTIC) and for whom no standard therapy exists

Study Overview

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

Detailed Description

This is an open-label phase I/II study and consists of three parts. In 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 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 will receive two dose level of TRK-950 in combination with Nivolumab. In Part 3, patients with histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma), who received prior chemotherapy with DTIC and for whom no standard therapy exists will receive one dose level of TRK-950. 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): 49
• Phase: Phase 2; 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
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Recruiting
      • Nagoya City University Hospital
      • Contact: Principal Investigator
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 811-1395
      • Recruiting
      • National Hospital Organization Kyushu Cancer Center
      • Contact: Principal Investigator
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8543
      • Recruiting
      • Sapporo Medical University Hospital
      • Contact: Principal Investigator
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 860-8556
      • Recruiting
      • Kumamoto University Hospital
      • Contact: Principal Investigator
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Recruiting
      • Shinshu University Hospital
      • Contact: Principal Investigator
  • Niigata
    • Niigata, Niigata, Japan, 951-8566
      • Recruiting
      • Niigata Cancer Center Hospital
      • Contact: Principal Investigator
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Recruiting
      • Saitama Medical University International Medical Center
      • Contact: Principal Investigator
  • Shizuoka
    • Nagaizumi-chō, Shizuoka, Japan, 411-8777
      • Recruiting
      • Shizuoka Cancer Center
      • Contact: Principal Investigator
  • Tokyo
    • Chuo Ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital
      • Contact: Principal Investigator
    • Shinjuku-Ku, Tokyo, Japan, 160-8582
      • Recruiting
      • Keio University Hospital
      • Contact: Principal Investigator

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.
• Part 3: Patients with histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma), who received prior chemotherapy with DTIC and for whom no standard therapy exists
• 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

4

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); Biological: TRK-950; 10 mg/kg administered Intravenously over 60 minutes (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); Biological: TRK-950; 10 mg/kg administered Intravenously over 60 minutes (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); Biological: TRK-950; 10 mg/kg administered Intravenously over 60 minutes (weekly)
Experimental: Part 3: TRK-950; Melanoma; TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle.	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); Biological: TRK-950; 10 mg/kg administered Intravenously over 60 minutes (weekly)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2)	Number of participants with DLTs will be determined.	Up to Day 28
Number of participants with adverse events (AEs) (Part 1 and 2)	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) (Part 1 and 2)	Number of participants with AESIs will be assessed.	through study completion, an average of 1 year
Number of participants with serious adverse events (SAEs) (Part 1 and 2)	Number of participants with SAEs will be assessed.	through study completion, an average of 1 year
Objective response rate (ORR) (Part 3)	Objective response rate (ORR) is defined as the percentage of patients who achieved either complete response (CR) or partial response (PR) as assessed by independent central review (ICR) per RECIST Version 1.1.	Up to approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration curve (AUC) of Nivolumab (Part 2 only)		through study completion, an average of 1 year
Area under the concentration curve (AUC) of TRK-950 (Part 1 and 2)		through study completion, an average of 1 year
Maximum plasma concentration (Cmax) of TRK-950 (Part 1 and 2)		through study completion, an average of 1 year
Time to maximum plasma concentration (Tmax) of TRK-950 (Part 1 and 2)		through study completion, an average of 1 year
Terminal elimination half life (t1/2) of TRK-950 (Part 1 and 2)		through study completion, an average of 1 year
Total body clearance (CL) of TRK-950 (Part 1 and 2)		through study completion, an average of 1 year
Apparent volume of distribution (Vd) of TRK-950 (Part 1 and 2)		through study completion, an average of 1 year
Overall survival (OS) (Part 3)	Overall survival (OS) is defined as time from the first date of TRK-950 administration until the date of death due to any cause.	Up to approximately 12 months
Progression-free survival (PFS) (Part 3)	Progression-free survival (PFS) is defined as time from the first date of TRK-950 administration until progression per RECIST Version 1.1, or death due to any cause.	Up to approximately 12 months
Best overall response (BOR) (Part 3)	Best overall response (BOR) is defined as the best response among all responses at each time point from the first date of TRK-950 administration until progression per RECIST Version 1.1.	Up to approximately 12 months
Disease control rate (DCR) (Part 3)	Disease control rate (DCR) is defined as the percentage of patients with BOR of CR or PR or stable disease (SD) per RECIST Version 1.1.	Up to approximately 12 months
Duration of response (DOR) (Part 3)	Duration of response (DOR) is defined as the duration between the date of first documented response (CR or PR) and the date of progression per RECIST Version 1.1, or death due to any cause.	Up to approximately 12 months
Tumor change rate (Part 3)	Tumor change rate is defined as the percentage change in the sum of the longest diameters of target lesions, as assessed per RECIST Version 1.1, compared to baseline obtained at screening.	Up to approximately 12 months

Collaborators and Investigators

• Sponsor: Toray Industries, Inc

Publications and helpful links

General Publications

• Okano F, Saito T, Minamida Y, Kobayashi S, Ido T, Miyauchi Y, Wasai U, Akazawa D, Kume M, Ishibashi M, Jiang K, Aicher A, Heeschen C, Yonehara T. Identification of Membrane-expressed CAPRIN-1 as a Novel and Universal Cancer Target, and Generation of a Therapeutic Anti-CAPRIN-1 Antibody TRK-950. Cancer Res Commun. 2023 Apr 18;3(4):640-658. doi: 10.1158/2767-9764.CRC-22-0310. eCollection 2023 Apr.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

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 (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Melanoma; Nivolumab-eligible solid tumor
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; 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