PIK3CA Mutation Clinical Trials

6 recruitingLast updated: June 18, 2026

There are 6 actively recruiting pik3ca mutation clinical trials across 24 countries. Studies span Phase 1, Phase 2, Phase 3. Top locations include Fairfax, Virginia, United States, Houston, Texas, United States, Indianapolis, Indiana, United States. Updated daily from ClinicalTrials.gov.


PIK3CA Mutation Trials at a Glance

6 actively recruiting trials for pik3ca mutation are listed on ClinicalTrialsFinder across 6 cities in 24 countries. The largest study group is Phase 1 with 3 trials, with the heaviest enrollment activity in Fairfax, Houston, and Indianapolis. Lead sponsors running pik3ca mutation studies include Relay Therapeutics, Inc., Cogent Biosciences, Inc., and Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.

Browse pik3ca mutation trials by phase

Treatments under study

About PIK3CA Mutation Clinical Trials

Looking for clinical trials for PIK3CA Mutation? There are currently 4 studies actively recruiting participants. Clinical trials offer access to new treatments before they are widely available, and every approved therapy in use today was first tested through a clinical trial.

Below you can browse trials, sign up for alerts when new PIK3CA Mutation trials open, and view eligibility criteria for each study. Each listing includes the study phase, locations, and enrollment details.

Frequently Asked Questions

Common questions about PIK3CA Mutation clinical trials

A clinical trial is a carefully designed research study that tests new medical treatments, drugs, devices, or approaches in human volunteers. Every approved medication and treatment available today was proven safe and effective through clinical trials.

All clinical trials are reviewed and approved by Institutional Review Boards (IRBs) — independent committees that evaluate patient safety. Trials follow strict protocols, and your health is monitored closely throughout. You can withdraw at any time.

Not necessarily. Many trials compare the new treatment against the current standard of care, meaning all participants receive active treatment. When placebos are used, they are typically combined with standard treatment, not given alone. The trial description will always specify the design.

Under the Affordable Care Act, most private insurers are required to cover routine patient care costs during a clinical trial. The sponsor typically covers the investigational treatment itself. Medicare also covers routine costs for qualifying trials.

Yes. Participation is completely voluntary. You can withdraw at any time, for any reason, without it affecting your access to standard medical care.

Each trial has specific eligibility criteria — including age, diagnosis, disease stage, prior treatments, and general health. Browse the trials listed above and check their eligibility sections. You can also contact the trial site directly to discuss your situation.

Showing 16 of 6 trials

Recruiting
Phase 3

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

Breast CancerMetastatic Breast CancerHER2-negative Breast Cancer+3 more
Relay Therapeutics, Inc.540 enrolled192 locationsNCT06982521
Recruiting
Phase 2

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)

PIK3CA MutationVascular AnomaliesVascular Malformations+5 more
Relay Therapeutics, Inc.277 enrolled34 locationsNCT06789913
Recruiting
Phase 1

Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors

Breast CancerOvarian CancerCervical Cancer+6 more
Regor Pharmaceuticals Inc.63 enrolled4 locationsNCT07524322
Recruiting
Phase 1

A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors

Endometrial CancerHER2-low Breast CancerHR Positive/HER-2 Negative Breast Cancer+2 more
Cogent Biosciences, Inc.90 enrolled2 locationsNCT07383506
Recruiting
Phase 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

Breast CancerMetastatic Breast CancerHER2-negative Breast Cancer+4 more
Relay Therapeutics, Inc.930 enrolled37 locationsNCT05216432
Recruiting

Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study

Breast CancerBreast Cancer MetastaticBreast Carcinoma+37 more
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano3,500 enrolled24 locationsNCT06805812