Medical Information Only. Consult your healthcare provider before considering clinical trial enrollment.
PIK3CA Mutation: early-phase trial registry
3 of 4 indexed PIK3CA Mutation trials are currently recruiting, with more weight in Phase 1-2.
Corpus placement: #4,115 of 28,707 conditions by registered trial count.
4 US clinical trials · 3 currently recruiting · #4,115 of 28,707 conditions by registered trial count
PIK3CA Mutation: 4 US clinical trials tracked, 3 recruiting.
PIK3CA Mutation is the subject of 4 registered US clinical trials on ClinicalTrials.gov, 3 of them currently open to new participants. 1 are in Phase 3-4 (later-stage) and 3 in Phase 1-2 (earlier-stage). The most active sponsor is Relay Therapeutics, running 4 of these trials.
Enrollment posture brief
Registry condition pik3ca-mutation
OPEN 3 | RECR 75% | LATE 1 | EARLY 3 | RANK #4115 | SPON 4
Volume-matched condition peers
Nearest open-share peer: Activity, Motor (75% recruiting · 8 trials)
PIK3CA Mutation lists 3 open slots (75% of 4 indexed trials). Peers are matched on registered volume, not therapeutic-area browse lists. How peer matching works →
Key findings
What ClinicalTrials.gov does not surface for PIK3CA Mutation on its own pages , computed from the registry mirror as of 2026-08-08. Each line carries its own denominator so it can be quoted as it stands.
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PIK3CA Mutation is recruiting above its size-band peers.
3 of 4 indexed trials (75%) are open to enrollment, against a 46.5% average across 27,806 conditions with fewer than 20 trials. The peer set uses the same ClinicalTrials.gov-derived counts as this page.
Open and recent trials
4 total, page 1 of 1
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
Named interventions
Most-linked intervention names on PIK3CA Mutation records (sponsor-reported on ClinicalTrials.gov). Counts are trial links, not unique products.
US sites by state
Facility locations filed on PIK3CA Mutation trials. A trial with sites in several states counts in each.
Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.
Related
What to do with this PIK3CA Mutation page
4 registered trials, 3 currently recruiting, is a starting point for a conversation, not a diagnosis or a recommendation.
- 3 PIK3CA Mutation trials are currently recruiting, check eligibility criteria before contacting a site. Browse recruiting trials
- Relay Therapeutics sponsors the most PIK3CA Mutation trials on record, review their full trial history before evaluating a specific study. See Relay Therapeutics's trials
- Bring the specific trial ID (NCT number) to your own doctor before enrolling, this page is a directory, not medical guidance. Read the trial-finding guide
Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This PIK3CA Mutation condition card totals 4 registered trials; most-linked intervention RLY-2608; top US site state Indiana. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.