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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 (The ReInspire Study)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site contacts updated at 1 of 40 sitesv12
  2. Trial sites expanded: 34 → 40 locationsv11
  3. Trial sites expanded: 31 → 34 locations
    • Eligibility criteria expanded, about 2 words
    • Study title expanded, about 3 words
    v10
  4. Trial sites expanded: 25 → 31 locationsv9
  5. Study sites: 12 to 25v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 9 to 12v7
  2. Study sites: 7 to 9v6
  3. Site contacts updated at 1 of 7 sitesv5
  4. Study sites: 4 to 7v4
  5. Enrollment target: 280 to 277v3 Show 4 more changesShow less
    • Study sites: 1 to 4
    • Start date changed from estimate of Apr 2025 to Jun 13, 2025
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (9)
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Mar 2025 to Apr 2025
    • Eligibility criteria expanded, about 40 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα 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.
Trial Details
NCT Number NCT06789913
Lead Sponsor Relay Therapeutics, Inc.
Conditions
(from sponsor)		 PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations, Vascular Malformations, PIK3CA Mutation, CLOVES Syndrome, Klippel Trenaunay Syndrome, Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP), Vascular Anomalies
Related terms Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi, Klippel-Trenaunay-Weber Syndrome, Lymphatic Abnormalities, Megalencephaly cutis marmorata telangiectatica congenita, Vascular Malformations
Enrollment 277 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov