Status:
UNKNOWN
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
Lead Sponsor:
Silverback Therapeutics
Conditions:
HER2 Positive Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
Detailed 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 P...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04460456
Start Date
July 27 2020
End Date
December 1 2022
Last Update
June 30 2022
Active Locations (12)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Duke University
Durham, North Carolina, United States, 27708
3
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
4
Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee, United States, 37203