Use the hyperlinks, where available to access additional clinical trial information.
A phase 1, open label, multi-center, dose escalation study of the safety, tolerability, pharmacokinetic and pharmacodynamic properties of intravenously administered APG-1387 in patients with advanced solid tumors and lymphomas
Jiangsu Ascentage Pharma Inc
This study aims to establish the safety and best tolerated dose of a new investigational drug called APG-1387 in participants with advanced cancer.
Who is it for?
You may be eligible to join this study if you are aged 18 years or more and have been diagnosed with an advanced solid tumour or lymphoma.
All participants in this study will be treated with a new investigational drug called APG-1387. This drug blocks tumour growth by promoting cell death (a process called apoptosis) in cancer cells and attempts to stop the cancer cells from spreading further throughout the body. This drug has not previously been tested in humans. APG-1387 has undergone extensive testing in various animal models (including rats and monkeys) and human cancer cell models in the laboratory. APG-1387 will be administered via intravenous (IV) infusion (i.e. directly into the vein) on Days 1, 8 and 15 of study participation. The first group of participants will receive a dose of 0.3 mg of APG-1387, and if tolerated the dose will be increased for subsequent patient groups. Participants will be regularly monitored until they reach their endpoint (disease progression, intolerable toxicity or withdrawal of consent) in order to determine safety, tolerability and preliminary efficacy of treatment. The results from this study will be analysed to see if it is worthwhile for this new drug to be tested in future studies involving larger numbers of cancer participants.