A Phase 2 Study of Mutant-selective PI3K? Inhibitor, RLY-2608, inAdults and Children with PIK3CA Related Overgrowth Spectrumand Malformations Driven by PIK3CA Mutation

This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kalpha inhibitor, zovegalisib (RLY-2608), in adults and children with PIK3CA Related Overgrowth Spectrum (PROS) and malformations driven by PIK3CA mutation. Part 1 is a dose selection, Part 2 is a basket design with exploratory single-arm cohorts for various subpopulations of participants, and Part 3 is randomized, double-blinded study vs placebo.

Study ID: 6149
NCT Number: 06789913
Principal Investigator: Kimberly Eisenstein, MD
Department: Dermatology-Derm
Eligibility: Both men and women 2 years old to 100 years old. Does not accept healthy volunteers.

For questions about this study, please contact:

ClinicalTrialsInterest@health.missouri.edu
(573) 882-7026