# 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** · PHASE2 · RECRUITING · sponsor: **Relay Therapeutics, Inc.** · enrollment: 277 (estimated)

## Conditions studied

- 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
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT06789913
- **Lead sponsor:** Relay Therapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-06-13
- **Primary completion:** 2031-07
- **Final completion:** 2031-10
- **Target enrollment:** 277 (ESTIMATED)
- **Last updated:** 2026-05-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06789913

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT06789913. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*