Loading clinical trials...

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

NCT05307705•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)
•Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.
•Have stopped all cancer treatment and have recovered from the major side effects
•Have adequate organ function, as measured by blood tests
•Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
•Patients must have
•* Measurable disease
•\--- Patients with non-breast tumor types must have at least 1 measurable lesion
•* Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only)
•For patients with an estrogen receptor (ER)+ breast cancer diagnosis:
+28 more criteria

Exclusion Criteria

•Medical Conditions
•* Colorectal cancer
•* Endometrial cancers with specific concurrent oncogenic alterations
•* A history of known active or suspected
•* Diabetes mellitus Type 1 or
•* Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C).
•* Serious concomitant systemic disorder
•Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
•Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process
•Prior exposure to phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) inhibitor(s), except in certain circumstances

Locations (50)

Mayo Clinic of Scottsdale

Scottsdale, Arizona, United States

UCLA Medical Center

Los Angeles, California, United States

UCSF Medical Center at Mission Bay

San Francisco, California, United States

Stanford University Hospital

Stanford, California, United States

Mayo Clinic

Jacksonville, Florida, United States

Winship Cancer Center Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University Medical School

St Louis, Missouri, United States

Key Dates

Start Date

May 11, 2022

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

March 2, 2026

Enrollment

193

ACTUAL participants

Conditions

Breast Cancer

Interventions

LOXO-783

DRUG

Fulvestrant

DRUG

Imlunestrant

DRUG

Abemaciclib

DRUG

Anastrozole, Exemestane, or Letrozole

DRUG

Paclitaxel

DRUG

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

View study

RECRUITINGPHASE1

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

NCT05673200

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer