Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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.