A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
NCT ID: NCT04460456
Last Updated: 2022-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
58 participants
INTERVENTIONAL
2020-07-27
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SBT6050 Monotherapy
Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.
SBT6050
Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
SBT6050 and pembrolizumab
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
Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
pembrolizumab
400 mg IV
SBT6050 and cemiplimab
SBT6050 in combination with cemiplimab in Part 5 at the recommended dose determined in Parts 1 and 3.
SBT6050
Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
Cemiplimab
350 mg IV
Interventions
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SBT6050
Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
pembrolizumab
400 mg IV
Cemiplimab
350 mg IV
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Silverback Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Naomi Hunder, MD
Role: STUDY_DIRECTOR
Silverback Therapeutics
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Duke University
Durham, North Carolina, United States
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
The START Center for Cancer Care
San Antonio, Texas, United States
Macquarie University Hospital Clinical Trials Unit
Sydney, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Breast Cancer Research Centre - WA
Nedlands, Western Australia, Australia
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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SBT6050-101
Identifier Type: -
Identifier Source: org_study_id
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