Clinical Trials

Inclusion Criteria:

- 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 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 phosphatidylinositol 3-kinase/protein kinase B/mammalian target of
rapamycin (PI3K/AKT/mTOR) inhibitor(s), except in certain circumstances

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/26/2024. Questions regarding updates should be directed to the study team contact.