A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with pembrolizumab in HER2 expressing or amplified advanced malignancies
This study has 4 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 2. Part 4 of the study will further evaluate SBT6050 in combination with pembrolizumab
in select HER2 expressing or amplified advanced malignancies
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | July 27, 2020 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: The proportion of subjects experiencing dose limiting toxicities
Primary Outcome 1 - Time Frame: 28 days
Primary Outcome 2 - Measure: The incidence and severity of adverse events (AEs) and serious adverse events
Primary Outcome 2 - Time Frame: 2 years
Primary Outcome 3 - Measure: Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)
Primary Outcome 3 - Time Frame: 2 years
Primary Outcome 4 - Measure: Duration of response, defined as the time from date of first response (CR or PR)
Primary Outcome 4 - Time Frame: 2 years
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)<br/>
- 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.
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Naomi Hunder, MD
Role: Study Director
Affiliation: Silverback Therapeutics
Name: VP Clinical Operations
Phone: (206) 456-2900
Email: ClinOps@Silverbacktx.com
Facility | Status | Contact |
---|---|---|
Investigative Site Boston, Massachusetts 02114 United States |
Recruiting | |
Investigative Site Pittsburgh, Pennsylvania 15232 United States |
Recruiting | |
Investigative Site Nashville, Tennessee 37203 United States |
Recruiting | |
Investigative Site Houston, Texas 77030 United States |
Recruiting | |
Investigative Site San Antonio, Texas 78229 United States |
Recruiting | |
Investigative Site Sydney, New South Wales 2109 Australia |
Recruiting | |
Investigative Site Melbourne, Victoria 3000 Australia |
Recruiting | |
Investigative Site Nedlands, Western Australia 6009 Australia |
Recruiting |