Updates

Texas Children's Cancer and Hematology Center A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children with PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation

<p>A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children with PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation</p>

This Phase 2 study evaluates the safety and effectiveness of the RLY-2608 medication in children and adults with PIK3CA-related overgrowth conditions.

Description

PIK3CA-Related Overgrowth Spectrum (PROS) is a group of rare conditions caused by mutations in the PIK3CA gene, leading to abnormal tissue growth and blood vessels malformations. RLY-2608 is a new drug designed to specifically target and block the mutated PI3Kα protein, which may help reduce or control the overgrowth. This study is important because it focuses on a targeted treatment for people with these rare genetic changes. The trial also includes analysis of biomarkers to better understand how the drug works in different individuals.

Eligibility

  • Children (2 years and older), adolescents, and adults
  • Confirmed diagnosis of a PIK3CA-related overgrowth condition
  • Adequate performance status to participate in the study
  • Presence of a PIK3CA mutation

Detailed inclusion and exclusion criteria are listed at clinicaltrials.gov

Contact

Ionela Iacobas, MD
Texas Children’s Hospital Vascular Anomalies Center
ixiacoba@texaschildrens.org 
832-822-3800