A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Recruiting · NCT05307705 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
50 locations listed across 10 US states.
- 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
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Wilmot Cancer Institute - Rochester, New York, United States
- Tennessee Oncology PLLC - Nashville, Tennessee, United States
- Texas Oncology-Baylor Charles A. Sammons Cancer Center - Dallas, Texas, United States
- UT Southwestern Medical Center - Dallas, Texas, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- South Texas Accelerated Research Therapeutics (START) - San Antonio, Texas, United States
- Cancer Research SA - Adelaide, Australia
- Institut Jules Bordet - Anderlecht, Belgium
- Hospital Universitario Quiron Dexeus - Barcelona, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Hospital Clinic de Barcelona - Barcelona, Spain
- Beijing Cancer hospital - Beijing, China
- National Cancer Center Hospital - Chūōku, Japan
- Peter Maccallum Cancer Institute Erb - East Melbourne, Australia
- Universitätsklinikum Erlangen - Erlangen, Germany
- Kyoto University Hospital - Kyoto, Japan
- The Cancer Institute Hospital of JFCR - Kōtō City, Japan
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Leuven, Belgium
- Royal Marsden NHS Trust - London, United Kingdom
- Centre Leon Berard - Lyon, France
- Hospital General Universitario Gregorio Maranon - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Aichi Cancer Center Hospital - Nagoya, Japan
- The Third Hospital of Nanchang - Nanchang, China
- Institut Curie - Paris, France
- Hospital Quironsalud Madrid - Pozuelo de Alarcón, Spain
- Institut de Cancérologie de l'Ouest - Saint-Herblain, France
- Samsung Medical Center - Seoul, South Korea
- Asan Medical Center - Seoul, South Korea
- Fudan University Shanghai Cancer Center - Shanghai, China
- National Cancer Centre Singapore - Singapore, Singapore
- ICANS_Institut de Cancerologie Strasbourg Europe - Strasbourg, France
- Royal Marsden Hospital (Sutton) - Sutton, United Kingdom
- St Vincent's Hospital - Sydney, Australia
- Princess Margaret Hospital (Hong Kong) - Toronto, Canada
- Hospital Clinico Universitario de Valencia - Valencia, Spain
- Hospital Arnau de Vilanova Valencia - Valencia, Spain
- BC Cancer Vancouver - Vancouver, Canada
- Gustave Roussy - Villejuif, France