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ClinicalTrials.gov public records Last synced Sep 14, 2026, 1:48 AM EDT

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Showing 25–43 of 19 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: PIK3CA Mutations Clear all
Completed Phase 1 Interventional

Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma

NCT01473095
View directory record Official record
Conditions
Solid Tumor, Malignant Lymphoma, Tumor
Interventions
ARQ 092
Drug
Lead sponsor
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Industry
Eligibility
18 Years and older
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2017
U.S. locations
7
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Miami, Florida + 3 more
Source: ClinicalTrials.gov public record
Updated Oct 22, 2017 · Synced Sep 14, 2026, 1:48 AM EDT
Recruiting Phase 1 Interventional

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

NCT07383506
View directory record Official record
Conditions
PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2-low Breast Cancer
Interventions
CGT6297
Drug
Lead sponsor
Cogent Biosciences, Inc.
Industry
Eligibility
18 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
11
States / cities
Scottsdale, Arizona • Los Angeles, California • Denver, Colorado + 8 more
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Sep 14, 2026, 1:48 AM EDT
Completed No phase listed Observational

Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer

NCT05982886
View directory record Official record
Conditions
Breast Cancer
Interventions
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
1,093 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Aug 8, 2023 · Synced Sep 14, 2026, 1:48 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)

NCT05490771
View directory record Official record
Conditions
Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Multiple Myeloma
Interventions
Biopsy Procedure, Computed Tomography, Copanlisib Hydrochloride, Magnetic Resonance Imaging
Procedure · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2027
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 4, 2026 · Synced Sep 14, 2026, 1:48 AM EDT
Terminated Phase 1Phase 2 Interventional

First in Human Trial of Topical VT30 in Pts With Venous/Lymphatic Malformations Assoc With PIK3CA or TEK Gene Mutations

NCT04409145
View directory record Official record
Conditions
Venous Malformation, Lymphatic Malformation, Venolymphatic Malformation
Interventions
VT30
Drug
Lead sponsor
Venthera, Inc., a BridgeBio company
Industry
Eligibility
18 Years to 60 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
15
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Palo Alto, California + 12 more
Source: ClinicalTrials.gov public record
Updated Aug 3, 2022 · Synced Sep 14, 2026, 1:48 AM EDT
Completed Phase 1 Interventional

Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors

NCT04344795
View directory record Official record
Conditions
Solid Tumor, Colorectal Cancer, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma, Endometrial Cancer, Gastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma, Solid Tumors With PIK3Ca Mutation
Interventions
TPST-1495 twice daily, TPST-1495 once daily or on intermittent schedule, Pembrolizumab
Drug
Lead sponsor
Tempest Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
89 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
11
States / cities
Aurora, Colorado • Baltimore, Maryland • Springfield, Massachusetts + 8 more
Source: ClinicalTrials.gov public record
Updated Sep 11, 2025 · Synced Sep 14, 2026, 1:48 AM EDT
Completed Phase 1 Interventional

Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery

NCT03317119
View directory record Official record
Conditions
Metastatic Colon Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Rectal Carcinoma, RAS Family Gene Mutation, Stage III Colon Cancer AJCC v7, Stage III Colorectal Cancer AJCC v7, Stage III Rectal Cancer AJCC v7, Stage IIIA Colon Cancer AJCC v7, Stage IIIA Colorectal Cancer AJCC v7, Stage IIIA Rectal Cancer AJCC v7, Stage IIIB Colon Cancer AJCC v7, Stage IIIB Colorectal Cancer AJCC v7, Stage IIIB Rectal Cancer AJCC v7, Stage IIIC Colon Cancer AJCC v7, Stage IIIC Colorectal Cancer AJCC v7, Stage IIIC Rectal Cancer AJCC v7, Stage IV Colon Cancer AJCC v7, Stage IV Colorectal Cancer AJCC v7, Stage IV Rectal Cancer AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVA Rectal Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7, Stage IVB Rectal Cancer AJCC v7
Interventions
Laboratory Biomarker Analysis, Trametinib, Trifluridine and Tipiracil Hydrochloride
Other · Drug
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
8
States / cities
Corona, California • Duarte, California • Lancaster, California + 5 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2024 · Synced Sep 14, 2026, 1:48 AM EDT
Terminated Phase 3 Interventional Results available

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

NCT04251533
View directory record Official record
Conditions
Triple Negative Breast Neoplasms
Interventions
alpelisib, placebo, nab-paclitaxel
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
137 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
5
States / cities
Los Angeles, California • Baton Rouge, Louisiana • Rochester, Minnesota + 2 more
Source: ClinicalTrials.gov public record
Updated Sep 9, 2026 · Synced Sep 14, 2026, 1:48 AM EDT
Recruiting Phase 1Phase 2 Interventional

Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer

NCT05455619
View directory record Official record
Conditions
HR+/HER2-negative Breast Cancer, Metastatic Breast Cancer
Interventions
Evexomostat
Drug
Lead sponsor
SynDevRx, Inc.
Industry
Eligibility
18 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
10
States / cities
Loma Linda, California • Newport, California • San Diego, California + 7 more
Source: ClinicalTrials.gov public record
Updated Apr 21, 2026 · Synced Sep 14, 2026, 1:48 AM EDT
Completed Phase 2 Interventional Results available

Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

NCT05054725
View directory record Official record
Conditions
Non-Small Cell Lung Cancer
Interventions
RMC-4630, Sotorasib
Drug
Lead sponsor
Revolution Medicines, Inc.
Industry
Eligibility
18 Years and older
Enrollment
47 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
23
States / cities
Fort Myers, Florida • Plantation, Florida • Saint Augustine, Florida + 20 more
Source: ClinicalTrials.gov public record
Updated Jan 5, 2026 · Synced Sep 14, 2026, 1:48 AM EDT
Active, not recruiting Phase 1 Interventional

GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases

NCT04192981
View directory record Official record
Conditions
Brain Metastases, Leptomeningeal Metastasis
Interventions
GDC-0084, whole brain radiation therapy radiation
Drug · Radiation
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
9
States / cities
Miami, Florida • Basking Ridge, New Jersey • Middletown, New Jersey + 6 more
Source: ClinicalTrials.gov public record
Updated Apr 21, 2026 · Synced Sep 14, 2026, 1:48 AM EDT
Recruiting Phase 1 Interventional

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

NCT05216432
View directory record Official record
Conditions
PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor
Interventions
RLY-2608, Fulvestrant, Palbociclib 125mg, Ribociclib 400mg, Ribociclib 600mg, PF-07220060 100mg, PF-07220060 300 mg
Drug
Lead sponsor
Relay Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
930 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
24
States / cities
Tucson, Arizona • San Diego, California • Denver, Colorado + 17 more
Source: ClinicalTrials.gov public record
Updated Sep 21, 2025 · Synced Sep 14, 2026, 1:48 AM EDT
Completed Phase 2 Interventional Results available

Akt Inhibitor MK2206 in Treating Patients With Advanced Breast Cancer

NCT01277757
View directory record Official record
Conditions
Recurrent Breast Carcinoma, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
Interventions
Akt Inhibitor MK2206, Laboratory Biomarker Analysis, Pharmacological Study
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
5
States / cities
Boston, Massachusetts • New York, New York • Nashville, Tennessee + 1 more
Source: ClinicalTrials.gov public record
Updated Dec 18, 2018 · Synced Sep 14, 2026, 1:48 AM EDT
Completed Phase 1 Interventional

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

NCT05759949
View directory record Official record
Conditions
PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor, Hormone Receptor Positive Tumor
Interventions
RLY-5836, Fulvestrant, Palbociclib, Ribociclib, Abemaciclib
Drug
Lead sponsor
Relay Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
7
States / cities
Orlando, Florida • Indianapolis, Indiana • Boston, Massachusetts + 4 more
Source: ClinicalTrials.gov public record
Updated May 15, 2025 · Synced Sep 14, 2026, 1:48 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer

NCT04108858
View directory record Official record
Conditions
Anatomic Stage IV Breast Cancer AJCC v8, HER2-Positive Breast Carcinoma, Metastatic Breast Carcinoma
Interventions
Copanlisib, Pertuzumab, Trastuzumab
Drug · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
5
States / cities
Los Angeles, California • Aurora, Colorado • Oklahoma City, Oklahoma + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 30, 2025 · Synced Sep 14, 2026, 1:48 AM EDT
Recruiting Phase 3 Interventional

A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

NCT07174336
View directory record Official record
Conditions
Breast Neoplasms, Neoplasm Metastasis
Interventions
LY4064809, Placebo, Ribociclib, Palbociclib, Abemaciclib, Anastrozole, Letrozole, Exemestane, Fulvestrant
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
800 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2033
U.S. locations
127
States / cities
Anchorage, Alaska • Chandler, Arizona • Phoenix, Arizona + 109 more
Source: ClinicalTrials.gov public record
Updated Sep 7, 2026 · Synced Sep 14, 2026, 1:48 AM EDT
Completed Phase 2 Interventional Results available

Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer

NCT02728258
View directory record Official record
Conditions
Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Undifferentiated Carcinoma, Metastatic Endometrioid Adenocarcinoma, Recurrent Uterine Corpus Cancer
Interventions
Copanlisib, Laboratory Biomarker Analysis
Drug · Other
Lead sponsor
NRG Oncology
Other
Eligibility
18 Years and older · Female only
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
43
States / cities
New Haven, Connecticut • Deerfield Beach, Florida • Miami, Florida + 35 more
Source: ClinicalTrials.gov public record
Updated Feb 14, 2022 · Synced Sep 14, 2026, 1:48 AM EDT
Terminated Phase 2 Interventional Results available

SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes

NCT02644122
View directory record Official record
Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Interventions
SF1126
Drug
Lead sponsor
Ezra Cohen
Other
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
1
States / cities
La Jolla, California
Source: ClinicalTrials.gov public record
Updated Jul 10, 2018 · Synced Sep 14, 2026, 1:48 AM EDT
Completed No phase listed Observational

INST 1204: PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer

NCT03951389
View directory record Official record
Conditions
Colon Cancer
Interventions
Non-interventional
Other
Lead sponsor
New Mexico Cancer Research Alliance
Other
Eligibility
18 Years and older
Enrollment
750 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2019
U.S. locations
1
States / cities
Albuquerque, New Mexico
Source: ClinicalTrials.gov public record
Updated May 17, 2021 · Synced Sep 14, 2026, 1:48 AM EDT