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

What this study 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 join (things the study team will check)

✅ You may be able to join 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 --- Patients with non-breast tumor types must have at least 1 measurable lesion
  • Measurable disease
  • 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: ---- Prior CDK4/6 inhibitor therapy required.
  • 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.
  • 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

🚫 You may not be able to join 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 this trial is running

• 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

+ 38 more sites.

Who to contact

There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or · 13176154559 · ClinicalTrials.gov@lilly.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05307705.