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

October 14, 2021 updated by: Toray Industries, Inc

A Phase 1, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of TRK-950 Given Intravenously in Patients With Advanced Solid Tumors

  1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent
  2. To establish the dose of TRK-950 recommended for future phase 2 studies

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28 days in Arm 1.

Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to determine the dosing schedule. Up to six (6) patients will be enrolled respectively.

In parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in Arm 3.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • 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 Locations

  • France
      • Lyon, France, 69373
        • Centre Léon Bérard
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with histologically confirmed locally advanced or metastatic solid carcinomas in Arm 1
  • Patients with histologically confirmed locally advanced or metastatic colon cancer in Arm 2
  • Patients with histologically confirmed locally advanced or metastatic cholangiocarcinomas in Arm 3
  • Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatment
  • Measurable disease per RECIST 1.1 (primary or metastases)

Exclusion Criteria:

  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Pregnant or nursing women
  • Treatment with radiation therapy, surgery, chemotherapy, immunotherapy, or investigational therapy within four weeks prior to study entry
  • Unwillingness or inability to comply with procedures required in this protocol
  • Known active infection with HIV, hepatitis B, hepatitis C
  • Symptomatic brain metastases
  • Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  • Patients who are currently receiving any other investigational agent

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - TRK-950
  • Solid tumor
  • TRK-950 (Three dose levels will be explored during Arm 1)
Biological: TRK-950
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
Biological: TRK-950

Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle

High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle

Biological: TRK-950
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
Experimental: Arm 2 - TRK-950
  • Colon cancer
  • TRK-950 (Low dose and High dose)
Biological: TRK-950
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
Biological: TRK-950

Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle

High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle

Biological: TRK-950
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
Experimental: Arm 3 -TRK-950
  • Cholangiocarcinomas
  • TRK-950 (Low dose)
Biological: TRK-950
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
Biological: TRK-950

Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle

High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle

Biological: TRK-950
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse event
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
CTCAE version 4.03
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Blood pressure (mmHg)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Heart rate (bpm)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Respiratory rate (bpm)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Temperature (°F or °C)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Weight (lbs/kg)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Height (inches/cm)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Karnofsky performance status
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Electrocardiogram
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Clinical laboratory tests
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration curve(AUC)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Maximum plasma concentration(Cmax)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Time to maximum plasma concentration(Tmax)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Terminal elimination half life(t1/2)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Total body clearance(CL)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Apparent volume of distribution(Vd)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Tumor response rate
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Duration of response
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Time to progression
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Progression free survival
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Toray Industries, Inc

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)

March 6, 2017

Primary Completion (Actual)

September 16, 2019

Study Completion (Actual)

September 16, 2019

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 950P1V01

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

Yes

Studies a U.S. FDA-regulated device product

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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