Overview
A first-in-human (FIH) study using SBT6050 in HER2 expressing advanced malignancies
Description
This study has 2 parts. Part 1 will evaluate the safety, tolerability and activity of escalating doses of SBT6050 to estimate the maximum tolerated dose (MTD) and determine the dose recommended for Part 2. Part 2 of the study will further evaluate SBT6050 in select HER2 expressing advanced malignancies.
Eligibility
Inclusion Criteria:
- Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) solid tumor
- Subjects must have received prior therapies known to confer clinical benefit (unless ineligible or refused to receive)
- Measurable disease per RECIST 1.1
- Tumor lesion amenable for biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic, hepatic, and cardiac function
Exclusion Criteria:
- History of allergic reactions to certain components of SBT6050 or similar drugs
- Untreated brain metastases
- Active autoimmune disease or a documented history of autoimmune disease or syndrome
- Human immunodeficiency virus infection, active hepatitis B infection or hepatitis C infection
- Additional protocol defined inclusion/exclusion criteria may apply.