Title
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced Solid Tumors Expressing HER2
Phase
Phase 1Lead Sponsor
Silverback TherapeuticsStudy Type
InterventionalStatus
Active, not recruitingIndication/Condition
HER2 Positive Solid TumorsIntervention/Treatment
SBT6050 pembrolizumab ...Study Participants
58A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
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.
Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
400 mg IV
350 mg IV
Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.
Escalating doses of SBT6050 in combination with pembrolizumab in Part 3 followed by expansion in Part 4 at the recommended dose determined in Part 3.
SBT6050 in combination with cemiplimab in Part 5 at the recommended dose determined in Parts 1 and 3.
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.
