RecruitingRecruiting
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
NCT05307705 · Eli Lilly and Company
In plain English
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Official title
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
About this study
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
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
Study design
Enrollment target: 260 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-05-11
Estimated completion: 2026-12
Last updated: 2026-07-20
Interventions
Drug: LOXO-783Drug: FulvestrantDrug: ImlunestrantDrug: AbemaciclibDrug: Anastrozole, Exemestane, or LetrozoleDrug: Paclitaxel
Primary outcomes
- • 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)
- • 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)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactThere may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or · contact · ClinicalTrials.gov@lilly.com · 13176154559
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (50)
Mayo Clinic of ScottsdaleNot Yet Recruiting
Scottsdale, Arizona, United States
UCLA Medical CenterCompleted
Los Angeles, California, United States
UCSF Medical Center at Mission BayRecruiting
San Francisco, California, United States
Stanford University HospitalRecruiting
Stanford, California, United States
Mayo ClinicNot Yet Recruiting
Jacksonville, Florida, United States
Winship Cancer Center Emory UniversityCompleted
Atlanta, Georgia, United States
Massachusetts General HospitalCompleted
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteNot Yet Recruiting
Boston, Massachusetts, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Washington University Medical SchoolRecruiting
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer CenterCompleted
New York, New York, United States
Wilmot Cancer InstituteNot Yet Recruiting
Rochester, New York, United States
Tennessee Oncology PLLCCompleted
Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer CenterRecruiting
Dallas, Texas, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
University of Texas MD Anderson Cancer CenterNot Yet Recruiting
Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START)Not Yet Recruiting
San Antonio, Texas, United States
Cancer Research SANot Yet Recruiting
Adelaide, Australia
Peter Maccallum Cancer Institute ErbRecruiting
East Melbourne, Australia
St Vincent's HospitalRecruiting
Sydney, Australia
Institut Jules BordetNot Yet Recruiting
Anderlecht, Belgium
Universitaire Ziekenhuizen Leuven - Campus GasthuisbergRecruiting
Leuven, Belgium
Princess Margaret Hospital (Hong Kong)Recruiting
Toronto, Canada
BC Cancer VancouverRecruiting
Vancouver, Canada
Beijing Cancer hospitalRecruiting
Beijing, China
The Third Hospital of NanchangRecruiting
Nanchang, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, China
Centre Leon BerardRecruiting
Lyon, France
Institut CurieNot Yet Recruiting
Paris, France
Institut de Cancérologie de l'OuestRecruiting
Saint-Herblain, France
ICANS_Institut de Cancerologie Strasbourg EuropeRecruiting
Strasbourg, France
Gustave RoussyNot Yet Recruiting
Villejuif, France
Universitätsklinikum ErlangenNot Yet Recruiting
Erlangen, Germany
National Cancer Center HospitalRecruiting
Chūōku, Japan
The Cancer Institute Hospital of JFCRRecruiting
Kōtō City, Japan
Kyoto University HospitalNot Yet Recruiting
Kyoto, Japan
Aichi Cancer Center HospitalRecruiting
Nagoya, Japan
National Cancer Centre SingaporeNot Yet Recruiting
Singapore, Singapore
Samsung Medical CenterNot Yet Recruiting
Seoul, South Korea
Asan Medical CenterNot Yet Recruiting
Seoul, South Korea
Hospital Universitario Quiron DexeusRecruiting
Barcelona, Spain
Hospital Universitari Vall d'HebronNot Yet Recruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Hospital General Universitario Gregorio MaranonRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreNot Yet Recruiting
Madrid, Spain
Hospital Quironsalud MadridRecruiting
Pozuelo de Alarcón, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
Hospital Arnau de Vilanova ValenciaRecruiting
Valencia, Spain
Royal Marsden NHS TrustRecruiting
London, United Kingdom
Royal Marsden Hospital (Sutton)Not Yet Recruiting
Sutton, United Kingdom