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

April 6, 2026 updated by: Toray Industries, Inc

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2)
Time Frame: Up to Day 28
Number of participants with DLTs will be determined.
Up to Day 28
Number of participants with adverse events (AEs) (Part 1 and 2)
Time Frame: through study completion, an average of 1 year
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)
Time Frame: through study completion, an average of 1 year
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)
Time Frame: through study completion, an average of 1 year
Number of participants with SAEs will be assessed.
through study completion, an average of 1 year
Objective response rate (ORR) (Part 3)
Time Frame: Up to approximately 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the concentration curve (AUC) of Nivolumab (Part 2 only)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Area under the concentration curve (AUC) of TRK-950 (Part 1 and 2)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Maximum plasma concentration (Cmax) of TRK-950 (Part 1 and 2)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Time to maximum plasma concentration (Tmax) of TRK-950 (Part 1 and 2)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Terminal elimination half life (t1/2) of TRK-950 (Part 1 and 2)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Total body clearance (CL) of TRK-950 (Part 1 and 2)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Apparent volume of distribution (Vd) of TRK-950 (Part 1 and 2)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Overall survival (OS) (Part 3)
Time Frame: Up to approximately 12 months
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)
Time Frame: Up to approximately 12 months
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)
Time Frame: Up to approximately 12 months
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)
Time Frame: Up to approximately 12 months
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)
Time Frame: Up to approximately 12 months
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)
Time Frame: Up to approximately 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Toray Industries, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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