PI3Kα Inhibitor
LOXO-783
Phase
1
Enrolling
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*
Related Resources:
Key Inclusion Criteria
- Advanced breast cancer or another solid tumor with the presence of a PIK3CA H1047R mutation (or other sponsor and SRC-approved, activating PIK3CA mutations other than H1047R mutation)
- Adequate archival tumor tissue sample available or be approved by the sponsor for enrollment if no tumor sample is available
- Stopped all cancer treatment and have recovered from the major side effects
- Adequate organ function, as measured by blood tests
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must have measurable disease (patients with non-breast tumor types must have at least 1 measurable lesion) OR non-measurable bone disease (at least one bone lesion in breast cancer patients only)
- For patients with an estrogen-receptor-positive (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+/HER2- advanced breast cancer
- Patients may have had up to 5 prior regimens for advanced disease, depending on cohort. Prior cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor therapy required
- Phase 1b: Part B
- ER+/HER2- advanced breast cancer
- Patients may have had up to 2 prior regimens for advanced disease
- Phase 1b: 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
- Phase 1b: Part D
- Advanced breast cancer
- Patients may have had up to 5 prior regimens for advanced disease
- Phase 1b: Part E
- Advanced solid tumor
- Patients may have had up to 3 prior regimens for advanced disease
- Phase 1b: Part F (randomized)
- ER+/HER2- advanced breast cancer
- Patients may have had up to 5 prior regimens for advanced disease. Prior CDK4/6 inhibitor therapy required
Key Exclusion Criteria
- Medical conditions
- Colorectal cancer
- Endometrial cancers with specific concurrent oncogenic alterations
- A history of known active or suspected: diabetes mellitus Type 1; 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 PI3K/AKT/mTOR inhibitor(s), except in certain circumstances
*
This clinical trial is being conducted globally.
†
LOXO-783 is administered PO.
‡
Fulvestrant is administered intramuscularly.
§
Imlunestrant is administered PO.
‖
Aromatase inhibitor (anastrozole, exemestane, or letrozole) is administered PO.
¶
Abemaciclib is administered PO.
#
Paclitaxel is administered intravenously.
**
Multiple randomized dose levels of LOXO-783 with fulvestrant.
