Ireland
--:--IST
Active, not recruiting Phase 1

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

NCT05307705 · tracked via the Priya Life Science France tracker
Phase
Phase 1
Started
2022-05-11
Last updated
2026-10-14

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 (105) →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)

  • Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs) — During the first 28-day cycle of LOXO-783 treatment
    Number of patients with DLTs
  • Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities — During the first 28-day cycle of LOXO-783 treatment
    Number of patients with DLT-equivalent toxicities

Trial sites (50)

FacilityCityRegionStatus
Mayo Clinic of Scottsdale Scottsdale Arizona
UCLA Medical Center Los Angeles California
UCSF Medical Center at Mission Bay San Francisco California
Stanford University Hospital Stanford California
Mayo Clinic Jacksonville Florida
Winship Cancer Center Emory University Atlanta Georgia
Massachusetts General Hospital Boston Massachusetts
Dana-Farber Cancer Institute Boston Massachusetts
Mayo Clinic Rochester Minnesota
Washington University Medical School St Louis Missouri
Memorial Sloan Kettering Cancer Center New York New York
Wilmot Cancer Institute Rochester New York
Tennessee Oncology PLLC Nashville Tennessee
Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas
UT Southwestern Medical Center Dallas Texas
University of Texas MD Anderson Cancer Center Houston Texas
South Texas Accelerated Research Therapeutics (START) San Antonio Texas
Cancer Research SA Adelaide Australia
Peter Maccallum Cancer Institute Erb East Melbourne Australia
St Vincent's Hospital Sydney Australia
Institut Jules Bordet Anderlecht Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium
Princess Margaret Hospital (Hong Kong) Toronto Canada
BC Cancer Vancouver Vancouver Canada
Beijing Cancer hospital Beijing China
The Third Hospital of Nanchang Nanchang China
Fudan University Shanghai Cancer Center Shanghai China
Centre Leon Berard Lyon France
Institut Curie Paris France
Institut de Cancérologie de l'Ouest Saint-Herblain France
ICANS_Institut de Cancerologie Strasbourg Europe Strasbourg France
Gustave Roussy Villejuif France
Universitätsklinikum Erlangen Erlangen Germany
National Cancer Center Hospital Chūōku Japan
The Cancer Institute Hospital of JFCR Kōtō City Japan
Kyoto University Hospital Kyoto Japan
Aichi Cancer Center Hospital Nagoya Japan
National Cancer Centre Singapore Singapore Singapore
Samsung Medical Center Seoul South Korea
Asan Medical Center Seoul South Korea

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

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 France