A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
About the study
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
HER2 Positive Solid Tumors
Age (in years)
18+
Phase
Phase 1
Participants needed
58
Est. Completion Date
Dec 31, 2022
Treatment type
Interventional
Sponsor
Silverback Therapeutics
ClinicalTrials.gov identifier
NCT04460456
Study number
SBT6050-101
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