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Clinical Trials in China / NCT05307705
Recruiting Phase 1

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

NCT05307705 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2022-05-11
Last updated
2026-09-08

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

LOXO-783Fulvestrant →Imlunestrant →Abemaciclib →Anastrozole, Exemestane, or LetrozoleAll Anastrozole, Exemestane trials (2) →All Letrozole trials (57) →Paclitaxel →

LOXO-783: Oral

Fulvestrant: Intramuscular

Imlunestrant: Oral

Abemaciclib: Oral

Anastrozole, Exemestane, or Letrozole: Oral

Paclitaxel: Intravenous

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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: * If female, must be postmenopausal * If male, must agree to use hormone suppression * Phase 1a: \-- Dose escalation and backfill patients: * Advanced solid tumor * Patients may have had up to 5 prior regimens for advanced disease * Phase 1b: * Part A: * ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer * Patients may have had up to 5 prior regimens for advanced disease ---- Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required * Part B: * ER+/HER2- advanced breast cancer * Patients may have had up to 2 prior regimens for advanced disease. * Part C: * ER+/HER2- advanced breast cancer * Patients may have had up to 5 prior regimens for advanced disease. \---- Prior CDK4/6 inhibitor therapy required. * Have a diagnosis of diabetes mellitus Type 2 * Part D: * Advanced breast cancer * Patients may have had up to 5 prior regimens for advanced disease. * Part E: * Advanced solid tumor * Patients may have had up to 3 prior regimens for advanced disease advanced disease * Part F: * ER+/HER2- advanced breast cancer * Patients may have had up to 5 prior regimens for advanced disease * Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required 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

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Mayo Clinic of Scottsdale Scottsdale Arizona Not Yet Recruiting
UCLA Medical Center Los Angeles California Completed
UCSF Medical Center at Mission Bay San Francisco California Recruiting
Stanford University Hospital Stanford California Recruiting
Mayo Clinic Jacksonville Florida Not Yet Recruiting
Winship Cancer Center Emory University Atlanta Georgia Completed
Massachusetts General Hospital Boston Massachusetts Completed
Dana-Farber Cancer Institute Boston Massachusetts Not Yet Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Washington University Medical School St Louis Missouri Not Yet Recruiting
Memorial Sloan Kettering Cancer Center New York New York Completed
Wilmot Cancer Institute Rochester New York Not Yet Recruiting
Tennessee Oncology PLLC Nashville Tennessee Completed
Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas Not Yet Recruiting
UT Southwestern Medical Center Dallas Texas Recruiting
University of Texas MD Anderson Cancer Center Houston Texas Not Yet Recruiting
South Texas Accelerated Research Therapeutics (START) San Antonio Texas Not Yet Recruiting
Cancer Research SA Adelaide Australia Not Yet Recruiting
Peter Maccallum Cancer Institute Erb East Melbourne Australia Not Yet Recruiting
St Vincent's Hospital Sydney Australia Not Yet Recruiting
Institut Jules Bordet Anderlecht Belgium Not Yet Recruiting
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium Not Yet Recruiting
Princess Margaret Hospital (Hong Kong) Toronto Canada Not Yet Recruiting
BC Cancer Vancouver Vancouver Canada Recruiting
Beijing Cancer hospital Beijing China Not Yet Recruiting
The Third Hospital of Nanchang Nanchang China Recruiting
Fudan University Shanghai Cancer Center Shanghai China Not Yet Recruiting
Centre Leon Berard Lyon France Recruiting
Institut Curie Paris France Not Yet Recruiting
Institut de Cancérologie de l'Ouest Saint-Herblain France Recruiting
ICANS_Institut de Cancerologie Strasbourg Europe Strasbourg France Recruiting
Gustave Roussy Villejuif France Not Yet Recruiting
Universitätsklinikum Erlangen Erlangen Germany Not Yet Recruiting
National Cancer Center Hospital Chūōku Japan Recruiting
The Cancer Institute Hospital of JFCR Kōtō City Japan Recruiting
Kyoto University Hospital Kyoto Japan Not Yet Recruiting
Aichi Cancer Center Hospital Nagoya Japan Recruiting
National Cancer Centre Singapore Singapore Singapore Not Yet Recruiting
Samsung Medical Center Seoul South Korea Not Yet Recruiting
Asan Medical Center Seoul South Korea Not Yet Recruiting

+ 10 more sites — see the full list on the official registry below.

On this site

📄 Verzenio (abemaciclib) drug profile →

More Eli Lilly and Company trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05307705 on ClinicalTrials.gov ↗ ← All trials in China