A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
NCT ID: NCT05307705
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
193 participants
INTERVENTIONAL
2022-05-11
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1A: LOXO-783 Monotherapy Dose Escalation
LOXO-783 administered orally
LOXO-783
Oral
Phase 1B: Part A
LOXO-783 administered orally in combination with fulvestrant intramuscularly, imlunestrant orally, or an aromatase inhibitor orally
LOXO-783
Oral
Fulvestrant
Intramuscular
Imlunestrant
Oral
Anastrozole, Exemestane, or Letrozole
Oral
Phase 1B: Part B
LOXO-783 orally in combination with abemaciclib and either physician's choice aromatase inhibitor orally, fulvestrant intramuscularly, or imlunestrant orally
LOXO-783
Oral
Fulvestrant
Intramuscular
Imlunestrant
Oral
Abemaciclib
Oral
Anastrozole, Exemestane, or Letrozole
Oral
Phase 1B: Part C
LOXO-783 orally in combination with fulvestrant intramuscularly
LOXO-783
Oral
Fulvestrant
Intramuscular
Phase 1B: Part D
LOXO-783 orally in combination with paclitaxel intravenously
LOXO-783
Oral
Paclitaxel
Intravenous
Phase 1B: Part E
LOXO-783 orally
LOXO-783
Oral
Phase 1B: Part F
Multiple randomized dose levels of LOXO-783 orally with fulvestrant intramuscularly
LOXO-783
Oral
Fulvestrant
Intramuscular
Interventions
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LOXO-783
Oral
Fulvestrant
Intramuscular
Imlunestrant
Oral
Abemaciclib
Oral
Anastrozole, Exemestane, or Letrozole
Oral
Paclitaxel
Intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
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
Hospital Universitario Quiron Dexeus
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Quironsalud Madrid
Pozuelo de Alarcón, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Arnau de Vilanova Valencia
Valencia, , Spain
Royal Marsden NHS Trust
London, , United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, , United Kingdom
Countries
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Related Links
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A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Other Identifiers
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2022-000175-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
J4C-OX-JZUA
Identifier Type: OTHER
Identifier Source: secondary_id
LOXO-PIK-21001
Identifier Type: OTHER
Identifier Source: secondary_id
18394
Identifier Type: -
Identifier Source: org_study_id
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