Status:
ACTIVE_NOT_RECRUITING
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Lead Sponsor:
Eli Lilly and Company
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT05307705
Start Date
May 11 2022
End Date
December 1 2025
Last Update
December 30 2025
Active Locations (50)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic of Scottsdale
Scottsdale, Arizona, United States, 85259
2
UCLA Medical Center
Los Angeles, California, United States, 90095
3
UCSF Medical Center at Mission Bay
San Francisco, California, United States, 94158
4
Stanford University Hospital
Stanford, California, United States, 94305