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PIK3CA Mutation clinical trials
Every US clinical trial registered for PIK3CA Mutation — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.
4 US clinical trials · 3 currently recruiting
The research picture
PIK3CA Mutation has 4 registered US clinical trials, 3 of them open to new participants right now — about 75% of the total.
- 3
- recruiting participants now
- 75%
- of trials open to enrollment
- 1
- in Phase 3–4 (later-stage)
- 4
- top sponsor: Relay Therapeutics
Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.
Active & Recent Trials
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 Cancer
Relay Therapeutics
NCT05216432
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
Relay Therapeutics
NCT06982521
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
Relay Therapeutics
NCT06789913
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
Relay Therapeutics
NCT05759949
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 2 |
| Phase 2 | 1 |
| Phase 3 | 1 |
Top Sponsors
Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.
Reading the PIK3CA Mutation Trial Landscape
ClinicalTrials.gov lists 4 US studies indexed under PIK3CA Mutation, and 3 of those are currently open to recruitment — roughly 75% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.
The phase distribution for PIK3CA Mutation shows 1 late-stage studies (Phase 3 and Phase 4 combined) alongside 3 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.
Top sponsor activity for PIK3CA Mutation is led by Relay Therapeutics with 4 indexed trials, alongside 0 other organizations in the top contributor list. The list on this page surfaces up to 4 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.
Frequently Asked Questions
How many clinical trials are there for PIK3CA Mutation?
PlainTrial tracks 4 US clinical trials for PIK3CA Mutation, of which 3 are currently recruiting participants. Data sourced from ClinicalTrials.gov.
How do I find a recruiting trial for PIK3CA Mutation?
Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.
Is this data current?
Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.
Related
Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.
Read our methodology — how this data is sourced, computed, and verified.
Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.