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A Phase 1 Study Evaluating the Safety of TRK-950 in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Phase 1 Study Evaluating the Safety of TRK-950 in Patients With Advanced Solid Tumors

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

NCT02990481•Toray Industries, Inc

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (3)

Mayo Clinic

Phoenix, Arizona, United States

HonorHealth Research Institute

Scottsdale, Arizona, United States

Centre Léon Bérard

Lyon, France

Key Dates

Start Date

March 6, 2017

Primary Completion Date

September 16, 2019

Completion Date

September 16, 2019

Last Updated

April 16, 2025

Enrollment

ACTUAL participants

Conditions

Locally Advanced or Metastatic Solid CarcinomasColon CancerCholangiocarcinoma

Interventions

TRK-950

BIOLOGICAL

TRK-950

BIOLOGICAL

TRK-950

BIOLOGICAL

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1 Study Evaluating the Safety of TRK-950 in Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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