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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

NCT06789913 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2026-05-05

No results posted yet for this study

Summary

This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα 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.

Conditions

  • PIK3CA-Related Overgrowth Spectrum (PROS)
  • Lymphatic Malformations
  • Vascular Malformations
  • PIK3CA Mutation
  • CLOVES Syndrome
  • Klippel Trenaunay Syndrome
  • Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)

Interventions

DRUG

RLY-2608

RLY-2608 is a mutant-selective, oral PI3Kα inhibitor.

DRUG

Placebo

RLY-2608 matched-placebo

Sponsors & Collaborators

  • Relay Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-13
Primary Completion
2031-07-31
Completion
2031-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789913 on ClinicalTrials.gov