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Showing 1–21 of 21 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Solid Tumors With PIK3Ca Mutation Clear all
Terminated Phase 1Phase 2 Interventional Results available

A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors

NCT01708161
View directory record Official record
Conditions
PIK3CA Mutated Advanced Solid Tumors, PIK3CA Amplified Advanced Solid Tumors
Interventions
BYL719, AMG 479
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
47 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
4
States / cities
Los Angeles, California • Boston, Massachusetts • New York, New York + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 12, 2018 · Synced Jul 22, 2026, 8:29 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 Jul 22, 2026, 8:29 AM EDT
Terminated Phase 1 Interventional

Open-label Phase 1b Study of ARQ 092 in Combination With Anastrozole

NCT02476955
View directory record Official record
Conditions
Solid Tumors, Ovarian Cancer, Endometrial Cancer
Interventions
ARQ 092 + carboplatin + paclitaxel (Closed), ARQ 092 + paclitaxel (Closed), ARQ 092 + anastrozole
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 · Female only
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
5
States / cities
Grand Rapids, Michigan • New York, New York • Oklahoma City, Oklahoma + 2 more
Source: ClinicalTrials.gov public record
Updated Sep 29, 2020 · Synced Jul 22, 2026, 8:29 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)

NCT04439175
View directory record Official record
Conditions
Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Multiple Myeloma
Interventions
Taselisib
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2027
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 5, 2026 · Synced Jul 22, 2026, 8:29 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 Jul 22, 2026, 8:29 AM EDT
Recruiting Phase 1Phase 2 Interventional

First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

NCT05768139
View directory record Official record
Conditions
Breast Cancer, Solid Tumors, Adult
Interventions
STX-478, Fulvestrant, Ribociclib, Palbociclib, Letrozole, Anastrozole, Exemestane, Tamoxifen, Abemaciclib, Imlunestrant, Metformin
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
880 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2030
U.S. locations
28
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 22 more
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Jul 22, 2026, 8:29 AM EDT
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 Jul 22, 2026, 8:29 AM EDT
Active, not recruiting Phase 2 Interventional

Genetic Testing in Guiding Treatment for Patients With Brain Metastases

NCT03994796
View directory record Official record
Conditions
CDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, NTRK Family Gene Mutation, PI3K Gene Mutation, ROS1 Gene Mutation, KRAS G12C Mutation
Interventions
Abemaciclib, PI3K Inhibitor paxalisib, Entrectinib, Adagrasib
Drug
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2028
U.S. locations
435
States / cities
Anchorage, Alaska • Phoenix, Arizona • Scottsdale, Arizona + 306 more
Source: ClinicalTrials.gov public record
Updated Apr 12, 2026 · Synced Jul 22, 2026, 8:29 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 Jul 22, 2026, 8:29 AM EDT
Completed Phase 1 Interventional

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

NCT01219699
View directory record Official record
Conditions
Advanced Solid Tumors With an Alteration of the PIK3CA Gene, Estrogen Receptor Positive Breast Cancer
Interventions
BYL719, Fulvestrant
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
221 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2020
U.S. locations
5
States / cities
San Francisco, California • Boston, Massachusetts • Nashville, Tennessee + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 21, 2020 · Synced Jul 22, 2026, 8:29 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
4
States / cities
Scottsdale, Arizona • St Louis, Missouri • Austin, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 30, 2026 · Synced Jul 22, 2026, 8:29 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 Jul 22, 2026, 8:29 AM EDT
Terminated Phase 1 Interventional

Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations

NCT05300048
View directory record Official record
Conditions
Advanced Solid Tumor, PIK3CA Mutation, PTEN Loss of Function Mutation
Interventions
Serabelisib, Insulin Suppressing Diet, Nab paclitaxel
Drug · Other
Lead sponsor
Faeth Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
17
States / cities
Birmingham, Alabama • Anaheim, California • Los Angeles, California + 14 more
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced Jul 22, 2026, 8:29 AM EDT
Completed Phase 1 Interventional

Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

NCT01226316
View directory record Official record
Conditions
Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, Tumour Response, Advanced or Metastatic Breast Cancer, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, PIK3CA, AKT1, PTEN, ER Positive, HER2 Positive
Interventions
AZD5363
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 130 Years
Enrollment
285 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2024
U.S. locations
12
States / cities
Los Angeles, California • Stanford, California • West Hollywood, California + 8 more
Source: ClinicalTrials.gov public record
Updated Jun 28, 2025 · Synced Jul 22, 2026, 8:29 AM EDT
Recruiting Phase 1 Interventional

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

NCT07524322
View directory record Official record
Conditions
Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation, HER2- Negative Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor, Hormone Receptor Positive Tumor, Cervical Cancer
Interventions
RGT-490
Drug
Lead sponsor
Regor Pharmaceuticals Inc.
Industry
Eligibility
18 Years and older
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
5
States / cities
Los Angeles, California • Houston, Texas • San Antonio, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 21, 2026 · Synced Jul 22, 2026, 8:29 AM EDT
Active, not recruiting Phase 1 Interventional

First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

NCT06239467
View directory record Official record
Conditions
Advanced Cancer, Breast Cancer, Advanced Solid Tumors, PI3K Gene Mutation
Interventions
OKI-219, Fulvestrant, Trastuzumab, Tucatinib, Atirmociclib, Ribociclib
Drug
Lead sponsor
OnKure, Inc.
Industry
Eligibility
18 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
12
States / cities
Encinitas, California • La Jolla, California • Los Angeles, California + 9 more
Source: ClinicalTrials.gov public record
Updated Jul 5, 2026 · Synced Jul 22, 2026, 8:29 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 Jul 22, 2026, 8:29 AM EDT
Recruiting Phase 1Phase 2 Interventional

Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

NCT06993844
View directory record Official record
Conditions
Advanced Solid Tumors, Advanced Breast Cancer
Interventions
ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
Drug
Lead sponsor
Ensem Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
233 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
10
States / cities
Newport Beach, California • San Francisco, California • New Haven, Connecticut + 6 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Jul 22, 2026, 8:29 AM EDT
Completed Phase 1 Interventional

Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours

NCT02260661
View directory record Official record
Conditions
Advanced Solid Malignancies, Breast Cancer - ER+, HER2 -, Breast Cancer - ER+, HER2-, PIK3CA Gene Mutation
Interventions
AZD8835, AZD8835 in combination with fulvestrant
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 130 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
5
States / cities
Denver, Colorado • Greenville, South Carolina • Nashville, Tennessee + 2 more
Source: ClinicalTrials.gov public record
Updated Oct 9, 2016 · Synced Jul 22, 2026, 8:29 AM EDT
Recruiting Phase 1 Interventional

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

NCT05307705
View directory record Official record
Conditions
Breast Cancer
Interventions
LOXO-783, Fulvestrant, Imlunestrant, Abemaciclib, Anastrozole, Exemestane, or Letrozole, Paclitaxel
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
260 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
17
States / cities
Scottsdale, Arizona • Los Angeles, California • San Francisco, California + 12 more
Source: ClinicalTrials.gov public record
Updated Jul 19, 2026 · Synced Jul 22, 2026, 8:29 AM EDT
Terminated Phase 1 Interventional Results available

Vevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations (MK-4440-001)

NCT02761694
View directory record Official record
Conditions
Cancer, Solid Tumors
Interventions
Vevorisertib, Fulvestrant, Paclitaxel
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
78 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2021
U.S. locations
6
States / cities
Las Vegas, Nevada • Oklahoma City, Oklahoma • Charleston, South Carolina + 3 more
Source: ClinicalTrials.gov public record
Updated May 5, 2023 · Synced Jul 22, 2026, 8:29 AM EDT