NCT06789913 - 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 | Biotech Hunter

Enrollment

277

Participants

Timeline

Start Date

June 13, 2025

Primary Completion Date

July 31, 2031

Study Completion Date

October 31, 2031

Conditions

PIK3CA-Related Overgrowth Spectrum (PROS)Lymphatic MalformationsVascular MalformationsPIK3CA MutationCLOVES SyndromeKlippel Trenaunay SyndromeMegalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)

Interventions

DRUG

RLY-2608

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

DRUG

Placebo

RLY-2608 matched-placebo

Trial Locations (12)

30329

RECRUITING

Children's Hospital of Atlanta, Atlanta

44195

RECRUITING

Cleveland Clinic Children's, Cleveland

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

53715

RECRUITING

University of Wisconsin, Madison, Madison

55905

RECRUITING

Mayo Clinic, Rochester

63110

RECRUITING

Washington University School of Medicine, St Louis

72202

RECRUITING

Arkansas Children's Hospital, Little Rock

77030

RECRUITING

Texas Children's Hospital, Houston

80045

RECRUITING

Children's Hospital Colorado, Aurora

90095

RECRUITING

University of California, Los Angeles, Los Angeles

94158

RECRUITING

University of California, San Francisco, San Francisco

02115

RECRUITING

Boston Children's Hospital, Boston

All Listed Sponsors

lead

Relay Therapeutics, Inc.

INDUSTRY