Breast Cancer Clinical Trial
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
Summary
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
Full Description
This study has 5 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 or amplified advanced malignancies.
Part 3 will evaluate the safety, tolerability, and activity of escalating doses of SBT6050 in combination with pembrolizumab to estimate the MTD and determine the dose recommended for Part 4. Part 4 of the study will further evaluate SBT6050 in combination with pembrolizumab in select HER2 expressing or amplified advanced malignancies.
Part 5 of the study will evaluate the safety, tolerability, and activity of SBT6050 in combination with cemiplimab in select HER2 expressing or amplified advanced malignancies.
Eligibility Criteria
Inclusion Criteria:
Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) or amplified 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 or able to provide tissue from biopsy within last 6 months
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.
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There are 12 Locations for this study
Boston Massachusetts, 02114, United States
Durham North Carolina, 27708, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Sydney New South Wales, 2109, Australia
Melbourne Victoria, 3000, Australia
Nedlands Western Australia, 6009, Australia
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
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