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NCT05307705PHASE1Recruiting

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

Eli Lilly and Company

Start Date

5/11/2022

Completion Date

12/1/2026

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

LOXO-783

DRUG

Fulvestrant

DRUG

Imlunestrant

DRUG

Abemaciclib

DRUG

Anastrozole, Exemestane, or Letrozole

DRUG

Paclitaxel

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Conditions

Breast Cancer

Locations

Mayo Clinic of Scottsdale

Scottsdale, Arizona 85259

United States

UCLA Medical Center

Los Angeles, California 90095

United States

UCSF Medical Center at Mission Bay

San Francisco, California 94158

United States

Stanford University Hospital

Stanford, California 94305

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

Winship Cancer Center Emory University

Atlanta, Georgia 30322

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Mayo Clinic

Rochester, Minnesota 55905-0002

United States

Washington University Medical School

St Louis, Missouri 63110

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Wilmot Cancer Institute

Rochester, New York 14642

United States

Tennessee Oncology PLLC

Nashville, Tennessee 37203

United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas 75246

United States

UT Southwestern Medical Center

Dallas, Texas 75390-8884

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas 78229

United States

Cancer Research SA

Adelaide, 5000

Australia

Peter Maccallum Cancer Institute Erb

East Melbourne, 3002

Australia

St Vincent's Hospital

Sydney, 2010

Australia

Institut Jules Bordet

Anderlecht, 1070

Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, 3000

Belgium

Princess Margaret Hospital (Hong Kong)

Toronto, M5G 2M9

Canada

BC Cancer Vancouver

Vancouver, V5Z4E6

Canada

Beijing Cancer hospital

Beijing, 100036

China

The Third Hospital of Nanchang

Nanchang, 330009

China

Fudan University Shanghai Cancer Center

Shanghai, 200032

China

Centre Leon Berard

Lyon, 69373

France

Institut Curie

Paris, 75248

France

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805

France

ICANS_Institut de Cancerologie Strasbourg Europe

Strasbourg, 67033

France

Gustave Roussy

Villejuif, 94805

France

Universitätsklinikum Erlangen

Erlangen, 91054

Germany

National Cancer Center Hospital

Chūōku, 104-0045

Japan

The Cancer Institute Hospital of JFCR

Kōtō City, 135-8550

Japan

Kyoto University Hospital

Kyoto, 606-8507

Japan

Aichi Cancer Center Hospital

Nagoya, 464-8681

Japan

National Cancer Centre Singapore

Singapore, 169610

Singapore

Samsung Medical Center

Seoul, 06351

South Korea

Asan Medical Center

Seoul, 5505

South Korea

Hospital Universitario Quiron Dexeus

Barcelona, 08028

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Hospital General Universitario Gregorio Maranon

Madrid, 28007

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Quironsalud Madrid

Pozuelo de Alarcón, 28223

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

Hospital Arnau de Vilanova Valencia

Valencia, 46015

Spain

Royal Marsden NHS Trust

London, SW3 6JJ

United Kingdom

Royal Marsden Hospital (Sutton)

Sutton, SM2 5PT

United Kingdom