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

Phase 1

Completed

• Conditions: Locally Advanced or Metastatic Solid Carcinomas; Colon Cancer; Cholangiocarcinoma
• Interventions: Biological: TRK-950

• Registration Number: NCT02990481
• Lead Sponsor: Toray Industries, Inc

Brief 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.

Study Timeline

• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-13
• Study Start: 2017-03-06
• Primary Completion: 2019-09-16
• Study Completion: 2019-09-16
• Status Verified: 2024-11
• Last Update Submitted: 2025-04-13
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 2 - TRK-950	TRK-950	* Colon cancer * TRK-950 (Low dose and High dose)
Arm 1 - TRK-950	TRK-950	* Solid tumor * TRK-950 (Three dose levels will be explored during Arm 1)
Arm 3 -TRK-950	TRK-950	* Cholangiocarcinomas * TRK-950 (Low dose)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States

Centre Léon Bérard; 🇫🇷 Lyon, France