A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer

Inclusion criteria:

All patients

• Histologically-confirmed, advanced solid tumors
• Progressive, recurrent unresectable disease

Phase II expansion part (advanced breast cancer)

• Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive HER-2 expression status
• Disease progression/recurrence following hormonal or anti-HER-2 treatment for advanced disease
• At least one but not more than two prior chemotherapy regimens for the unresectable tumor
• Measurable disease by MRI or CT scan

Cowden Syndrome patients with an advanced malignancy Genetic confirmation of Cowden Syndrome

• Age ≥ 18
• World Health Organization (WHO) Performance Status of ≤ 2

Exclusion criteria:

• Hematopoietic:
• No diabetes mellitus or history of gestational diabetes mellitus
• No acute or chronic renal disease
• No acute or chronic liver disease
• No acute or chronic pancreatitis
• No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
• No acute myocardial infarction or unstable angina pectoris within the past 3 months
• Not pregnant or nursing and fertile patients must use barrier contraceptives

Other protocol-defined inclusion/exclusion criteria may apply.