CRISTAL-APC is a Phase I/II open-label clinical trial conducted in collaboration with Precision Panc sites across the UK. The Phase I portion of the study is designed to evaluate the safety, tolerability, and optimal dosing of VP-002 when administered alongside standard chemotherapy agents nab-paclitaxel and gemcitabine. Using a dose-escalation approach, the goal is to identify a recommended Phase II dose for patients with advanced pancreatic ductal adenocarcinoma (PDAC).
Following the determination of the recommended dose, the trial will progress to a randomised Phase II stage. This phase will assess whether the VP-002 combination is superior to the current standard-of-care chemotherapy (nab-paclitaxel and gemcitabine alone). It will involve patients with advanced PDAC who have not previously received systemic treatment. Participants with metastatic pancreatic adenocarcinoma in the first-line setting will be randomly assigned in a 2:1 ratio to receive either the experimental treatment or standard therapy.
ABOUT CRISTAL-APCPatients who have been diagnosed with cancer may have the opportunity to take part in early phase clinical trials through a recommendation from their consultant. These trials, often focusing on new and promising treatments, are typically suggested when standard options have been explored or when a trial may offer potential benefit. Consultants assess each patient’s individual condition, medical history, and eligibility criteria to identify suitable trials. If a relevant trial is available, the consultant will discuss the details, including potential risks and benefits, and refer the patient to the trial team for further information and assessment. Taking part in an early phase clinical trial is entirely voluntary and can offer access to cutting-edge therapies while contributing to the advancement of cancer research. If you are interested in taking part in a clinical trial or CRISTAL-APC, please speak with your consultant oncologist.
Healthcare professionals working on the CRISTAL-APC trial can access a secure, centralised area designed specifically for their training and reference needs. This protected platform provides up-to-date clinical trial documents, including protocols, investigator brochures, informed consent forms, and regulatory guidance. It also offers essential training modules to ensure all team members are fully prepared and compliant with study requirements.
By using this secure area, clinical trial staff can stay informed, streamline their workflow, and ensure accurate and consistent execution of the trial at every stage.
