Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Have 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)
- 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 one bone lesion in breast cancer patients
only)
- For patients with an 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, where standard curative or palliative measures are no longer effective or are not considered appropriate or safe in the opinion of the Investigator.
Note: At the Sponsor’s discretion, enrollment to Phase 1a backfill slots may be limited to select patient populations (e.g., ER+ HER2- advanced breast cancer patients) to ensure adequate evaluation of LOXO-783 safety, PK, pharmacodynamic, and/or clinical activity in populations of interest. \
- 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 2 to 4 prior regimens for advanced disease,
depending on cohort
- Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 8/25/23. Questions regarding updates should be directed to the study team contact.
- 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 2 prior regimens for advanced disease
- Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
Exclusion Criteria:
- 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 PI3K/AKT/mTOR inhibitor(s), except in certain circumstances
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 5/16/23. Questions regarding updates should be directed to the study team contact.