Expanded Access Policy
Advancing towards our vision of a future where cancer is no longer a grim diagnosis, Xilio is building a pipeline of novel, tumor-activated molecules, including cytokines and other biologics, that are designed to optimize their therapeutic index and localize anti-tumor activity within the tumor microenvironment without systemic effects.
We understand that some patients may wish to access our unapproved investigational drugs through a form of “Expanded Access Programs,” sometimes referred to as “Compassionate Use.” The key tenets of an expanded access program include avoiding unnecessary harm to patients and that the potential benefit of the investigational medicine to the patient is greater than the potential risk. At this early clinical stage of our development, we do not have sufficient evidence of clinical safety and efficacy of our investigational drugs to support an expanded access program. Therefore, Xilio does not currently offer an expanded access program. However, we may revise this policy in the future as additional clinical data become available for each of our investigational medicines.
We believe enrollment in our ongoing clinical trials is the safest and most effective way of achieving our vision, and we encourage all patients and physicians who are interested in accessing our investigational medicines to visit the clinicaltrials.gov website to learn more about our clinical trials.