Clinical trials
catalyst calendar across sponsors →Studies where RLAY is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
5 interventional
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| 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)NCT06789913Parts 1 and 2: Determination of a recommended phase 2 dose RP2D(s) for Groups 1, 2, and 3Randomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: RLY-2608, Placebo | PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations, Vascular Malformations, PIK3CA Mutation, CLOVES Syndrome, Klippel Trenaunay Syndrome, Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP), Vascular Anomalies | 277 | Jul 2031 | ≤ 1,807 d | 2026-08-12 |
| Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast CancerNCT06982521Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR)Randomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Zovegalisib, Capivasertib, Fulvestrant | PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer | 540 | 2028-04-30 | in 620 d | 2026-08-05 |
| A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid TumorsNCT07584226Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: RLY-8161 | Advanced NRAS-Mutant Melanoma, Advanced NRAS-Mutant Solid Tumors, NRAS Mutation, NRAS G12D, NRAS G13R, NRAS G13D, NRAS G12V, NRAS Q61R, NRAS Q61K, NRAS Q61L, NRAS Q61H | 35 | 2027-12-30 | in 498 d | 2026-07-02 |
| First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast CancerNCT05216432Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RLY-2608 as a single agentNon-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: RLY-2608, Fulvestrant, Palbociclib 125mg, Ribociclib 400mg, Ribociclib 600mg, PF-07220060 100mg, PF-07220060 300 mg | PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor | 930 | 2027-04-30 | in 254 d | 2025-09-22 |
| First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid TumorsNCT05759949Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of RLY-5836Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: RLY-5836, Fulvestrant, Palbociclib, Ribociclib, Abemaciclib | PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor, Hormone Receptor Positive Tumor | 41 | 2025-03-18actual | — | 2025-05-16 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19