Overview

A Phase 2 Study of Mutant-selective PI3K Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation

Status:
RECRUITING
Trial end date:
2031-10-01
Target enrollment:
Participant gender:
Summary
This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3K inhibitor, 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.
Phase:
PHASE2
Details
Lead Sponsor:
Relay Therapeutics, Inc.