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



Status:Recruiting
Conditions:Colorectal Cancer, Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:March 6, 2017
End Date:August 2019
Contact:Vicki Bauernschub, BSN,RN
Email:vbauernschub@td2inc.com
Phone:602 358 8324

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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

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 six (12) patients will be enrolled in Arm
3.

Once the dosing schedule has been established in Arm 2, up to 40 additional patients may be
enrolled in Arm 4 for confirmation of safety.

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

- Patients with histologically confirmed locally advanced or metastatic colon, gastric,
ovarian, bladder cancers, as well as cholangiocarcinomas or hepatomas in Arm 4

- 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, 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
We found this trial at
3
sites
Scottsdale, Arizona 85258
Phone: 480-323-1339
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Lyon, 69373
Phone: +33 (0)4 26 55 68 33
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Phone: 855-776-0015
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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