A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
Checked against the public recordLast updated Jun 30, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Silverback Therapeutics
- Interventions being studied
- Drug: SBT6050; Drug: pembrolizumab; Drug: Cemiplimab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Massachusetts General HospitalBoston, Massachusetts
- Duke UniversityDurham, North Carolina
- University of Pittsburgh Medical Center Hillman Cancer CenterPittsburgh, Pennsylvania
- Sarah Cannon Research Institute/Tennessee OncologyNashville, Tennessee
- MD Anderson Cancer CenterHouston, Texas
- The START Center for Cancer CareSan Antonio, Texas
- Macquarie University Hospital Clinical Trials UnitSydney, New South Wales
- Peter MacCallum Cancer CentreMelbourne, Victoria
- Breast Cancer Research Centre - WANedlands, Western Australia
- Seoul National University HospitalSeoul
- Asan Medical CenterSeoul
- Samsung Medical CenterSeoul
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 30, 2022. Always confirm current availability with the study team.