Phase I Dose Finding Study in Patients with HER2-Positive Advanced Solid Tumors

GQ1001 is an experimental cancer treatment being developed for people with HER2-positive advanced solid tumours. HER2 is a protein that appears in excess on the surface of certain cancer cells (most commonly breast and stomach cancers, but also other solid tumours) and drives their growth. GQ1001 is designed to target this protein and deliver a toxic payload directly to the cancer cells. This Phase 1 dose-finding study is the first time GQ1001 is being tested in humans. Five different doses will be tested across groups of patients, with each person receiving the drug once into a vein every 21 days. The main goal is to determine which dose is safe and how the body handles the medication, while also getting an early look at whether it shows signs of anti-cancer activity. You may be eligible if you are 18 or older and have a confirmed advanced or metastatic solid tumour that is HER2-positive (either by standard pathology tests or genetic profiling), and which has not responded to currently available treatments. You must have adequate kidney, liver, and heart function, and be in reasonably good general health. People with active brain metastases, blood cancers, significant heart problems, serious lung disease, or who are pregnant are not eligible.