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

Toray Industries

Status and phase: Completed; Phase 1

Conditions: Locally Advanced or Metastatic Solid Carcinomas; Colon Cancer; Cholangiocarcinoma

Treatments: Biological: TRK-950

Study type: Interventional

Funder types: Industry

Identifiers

NCT02990481

950P1V01

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

Arm 1 - TRK-950

Experimental group

Description:

* Solid tumor * TRK-950 (Three dose levels will be explored during Arm 1)

Treatment:

Biological: TRK-950

Biological: TRK-950

Biological: TRK-950

Arm 2 - TRK-950

Experimental group

Description:

* Colon cancer * TRK-950 (Low dose and High dose)

Treatment:

Biological: TRK-950

Biological: TRK-950

Biological: TRK-950

Arm 3 -TRK-950

Experimental group

Description:

* Cholangiocarcinomas * TRK-950 (Low dose)

Treatment:

Biological: TRK-950

Biological: TRK-950

Biological: TRK-950