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A phase 1 dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of ACT001 in patients with advanced solid tumors
Accendatech AU Pty Ltd
The primary purpose of this study is to evaluate the safety of a new cancer drug, ACT001 which has not yet been tested in humans. The study will also look at the amount of drug in the blood to evaluate the way the body processes the drug and the way the drug acts on the growth of tumours in cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been diagnosed with advanced or metastatic solid tumor, including glioblastoma, with no standard treatment options. Study details All participants in this study will receive a specified dose of ACT001 each day for 56 days (two 28 day cycles). The first set of participants will start on the lowest dose level, with the next highest dose only commencing in the next set of participants once the safety of the first dose has been confirmed. Researchers will take a number of blood samples on days 1, 2, 3, 17, 18 and 29 of dosing in each participant to examine the rate that the body processes the drug. Further blood samples, as well as CT and MRI scans will be taken before treatment and at the end of treatment to look for changes in tumour growth. Participants will also be assessed for side effects throughout the study period. It is hoped that the findings of this trial will show whether ACT001 can be safely given to cancer patients, and provide information on the rate of processing of the drug in the body. Using this information, researchers hope to find the best dose to use for further testing of ACT001 in cancer patients.