A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Recruiting now · Phase 1
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT05307705
- Run by
- Eli Lilly and Company
- People needed
- 260
- Starts
- 2022-05-11
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Institut de Cancérologie de l'Ouest — Saint-Herblain, France (enrolling)
- ICANS_Institut de Cancerologie Strasbourg Europe — Strasbourg, France (enrolling)
- UCSF Medical Center at Mission Bay — San Francisco, California, United States (enrolling)
- Stanford University Hospital — Stanford, California, United States (enrolling)
- National Cancer Center Hospital — Chūōku, Japan (enrolling)
- The Cancer Institute Hospital of JFCR — Kōtō City, Japan (enrolling)
- Princess Margaret Hospital (Hong Kong) — Toronto, Canada (enrolling)
- Aichi Cancer Center Hospital — Nagoya, Japan (enrolling)
- BC Cancer Vancouver — Vancouver, Canada (enrolling)
- UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- The Third Hospital of Nanchang — Nanchang, China (enrolling)
- Hospital Universitario Quiron Dexeus — Barcelona, Spain (enrolling)
- Fudan University Shanghai Cancer Center — Shanghai, China (enrolling)
- Hospital Clinic de Barcelona — Barcelona, Spain (enrolling)
- Hospital General Universitario Gregorio Maranon — Madrid, Spain (enrolling)
- Centre Leon Berard — Lyon, France (enrolling)
- Hospital Quironsalud Madrid — Pozuelo de Alarcón, Spain (enrolling)
- Hospital Clinico Universitario de Valencia — Valencia, Spain (enrolling)
- Hospital Arnau de Vilanova Valencia — Valencia, Spain (enrolling)
- Royal Marsden NHS Trust — London, United Kingdom (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Universitätsklinikum Erlangen — Erlangen, Germany
- Kyoto University Hospital — Kyoto, Japan
- National Cancer Centre Singapore — Singapore, Singapore
- Samsung Medical Center — Seoul, South Korea
Full record on ClinicalTrials.gov
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