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BRIEF TITLE: Study of SBT6050 Alone and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Expressing HER2

A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Expressing HER2


  • Org Study ID: SBT6050-101
  • Secondary ID:
  • NCT ID: NCT04460456
  • NCT Alias:
  • Sponsor: Silverback Therapeutics - Industry
  • Source: Silverback Therapeutics

Brief Summary

A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with pembrolizumab in HER2 expressing or amplified advanced malignancies

Detailed Description


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 Outcomes:

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

Condition:

  • HER2 Positive Solid Tumors

Eligibility

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

Official Information

Name: Naomi Hunder, MD

Role: Study Director

Affiliation: Silverback Therapeutics

Overall Contact

Name: VP Clinical Operations

Phone: (206) 456-2900

Email: ClinOps@Silverbacktx.com

Locations

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