Condition
PIK3CA Mutation clinical trials and research
As of November 12, 2026, Find a Trial lists 4 PIK3CA Mutation clinical trials that are recruiting, at sites in 27 countries (most in United States (4), Australia (3), France (3)). By phase: Phase 1 (2), Phase 2 (1), Phase 3 (1). Every study is explained in plain English. Data from ClinicalTrials.gov and NIH RePORTER, updated November 12, 2026.
- 4Clinical trials
- 27Countries
Newest PIK3CA Mutation clinical trials
| Study | Phase | Where | Status | Registered |
|---|---|---|---|---|
| RGT-490 for adults with PIK3CA-mutated advanced solid tumors | Phase 1 | Los Angeles, California and 5 other locations | Recruiting | Apr 13, 2026 |
| RLY-2608 plus fulvestrant versus capivasertib plus fulvestrant for PIK3CA‑mutant HR+/HER2‑ advanced breast cancer | Phase 3 | Gilbert, Arizona and 253 other locations | Recruiting | May 21, 2025 |
| Treatment for PIK3CA-related overgrowth and malformations using RLY-2608 | Phase 2 | Phoenix, Arizona and 39 other locations | Recruiting | Jan 23, 2025 |
| Testing a new drug for advanced solid tumors and breast cancer with specific mutations | Phase 1 | Tucson, Arizona and 36 other locations | Recruiting | Jan 31, 2022 |
All recruiting trials (4)
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RGT-490 for adults with PIK3CA-mutated advanced solid tumors
This trial will test RGT-490, an oral medicine, in adults whose advanced solid tumors carry a PIK3CA mutation and have progressed after prior therapy.
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RLY-2608 plus fulvestrant versus capivasertib plus fulvestrant for PIK3CA‑mutant HR+/HER2‑ advanced breast cancer
This trial tests whether RLY-2608 combined with fulvestrant works better than capivasertib combined with fulvestrant for adults with HR+/HER2‑ advanced breast cancer that has a PIK3CA mutation and progressed after a CDK4/6 inhibitor.
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Treatment for PIK3CA-related overgrowth and malformations using RLY-2608
This study is testing a new treatment called RLY-2608 to see if it can help adults and children with PIK3CA-related overgrowth and malformations feel better.
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Testing a new drug for advanced solid tumors and breast cancer with specific mutations
This study is testing a new drug called RLY-2608 to see if it can help people with advanced solid tumors and breast cancer that have specific mutations.
Related topics
Quick answers
How many PIK3CA Mutation clinical trials are recruiting right now?
4, as of November 12, 2026. We update this list each time we refresh our data from ClinicalTrials.gov.
Where are these trials running?
In 27 countries. The most sites are in United States (4 trials), Australia (3 trials), France (3 trials), Italy (3 trials), Spain (3 trials). Each study page lists its sites and which ones are recruiting.
What phases are they in?
Phase 1: 2, Phase 2: 1, Phase 3: 1. Trials with no phase listed are usually device, behavioural or observational studies.
How do I join one?
Open a study, check the "Is this trial a fit for you?" section, then contact the study team listed on the page. They will ask a few screening questions. Asking is free and does not commit you to anything. Talk it over with your doctor first.
Find the studies that fit you
A list is a starting point. Tell us your situation in your own words and we'll rank the studies that match and explain why. It's free and needs no account.