Relay Therapeutics’ clinical trial for individuals with vascular malformations, including lymphatic malformations, is currently enrolling eligible individuals 6 years and older at active sites in the United States, UK, Ireland, Belgium, Germany, Italy, Spain, and Australia. The trial was also recently approved in Norway, so a site is anticipated to open there in the future.
Clinicaltrials.gov contains a list of sites that are active and will be updated on an ongoing basis as new sites activate.
The clinical trial is evaluating the investigational drug zovegalisib (RLY-2608) to learn more about the safety and effectiveness of it in the treatment of individuals with PIK3CA-driven vascular malformations, including lymphatic malformations.
The clinical trial is designed to learn about a potential new treatment option, zovegalisib (RLY-2608), for PIK3CA-driven vascular malformations. These types of malformations are caused by mutations or changes in the PIK3CA gene, which create a malfunctioning form of the protein PI3Kα. When mutated, PI3Kα can cause vascular malformations and/or overgrowths throughout the body, along with other symptoms.
What Are PIK3CA-Driven Vascular Malformations?
PIK3CA-driven vascular malformations may include lymphatic malformations, both isolated and complex lymphatic anomalies, and PIK3CA-related overgrowth spectrum (PROS). PROS consists of syndromes such as Klippel-Trenaunay, CLOVES, FAVA, MCAP and more.
What is the Investigational Drug Zovegalisib (RLY-2608)?
Zovegalisib (RLY-2608) is a mutant-selective drug. This means it is designed to specifically hinder the mutated PI3Kα protein that can cause PIK3CA-driven vascular malformations. By selectively targeting the mutated protein and limiting impact on the normal protein that everyone needs for regular body functions, zovegalisib (RLY-2608) aims to reduce side effects and provide more effective treatment over non-mutant-selective therapies. Zovegalisib (RLY-2608) is the only known mutant-selective drug currently being studied for vascular malformations. It is taken orally.
Where are there active clinical trial sites?
There are active sites in in the United States, UK, Ireland, Belgium, Germany, Italy, Spain, and Australia. Clinicaltrials.gov contains a list of sites that are active and will be updated on an ongoing basis as new sites are activated.
As a reminder, the trial was also recently approved in Norway, so a site is anticipated to open there in the future.
Learn More
To learn more about the trial, there are brochures available in different languages here:
Adult Patients:
Caregivers:
Relay Therapeutics will host a webinar for the LM community in the upcoming weeks to review initial results from the clinical trial. Additional details, including how to register, will be announced soon.
About Relay Therapeutics
Relay Therapeutics is a small biotech company founded in 2016 that is focused on discovering and developing new medicines for both rare disease and oncology communities with significant unmet needs. Relay’s scientists have developed new tools to make the drug development process more efficient and effective by combining wet-lab experiments and computational tools, like AI simulations, to develop medicines for diseases that have historically been difficult to treat. The company’s lead investigational drug, zovegalisib (RLY-2608), is the first PIK3CA mutant-selective drug to enter clinical development and is currently being studied in clinical trials for PIK3CA-driven vascular malformations and HR+/HER2- metastatic breast cancer.
Questions for Relay Therapeutics? Email patientadvocacy@relaytx.com
