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Brief Title: A Study of SBT6050 Alone and in Combination With Pembrolizumab in Patients With Advanced HER2 Expressing Solid Tumors

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

INTRODUCTION

  • Org Study ID: SBT6050-101
  • Secondary ID: N/A
  • NTC ID: NCT04460456
  • Sponsor: 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


  • Overall Status
    Recruiting
  • Start Date
    July 27, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: The proportion of subjects experiencing dose limiting toxicities

Primary Outcome 1 - Timeframe: 28 days

Primary Outcome 2 - Measure: The incidence and severity of adverse events (AEs) and serious adverse events

Primary Outcome 2 - Timeframe: 2 years

Primary Outcome 3 - Measure: Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)

Primary Outcome 3 - Timeframe: 2 years

Primary Outcome 4 - Measure: Duration of response, defined as the time from date of first response (CR or PR)

Primary Outcome 4 - Timeframe: 2 years

CONDITION

  • HER2 Positive Solid Tumors

ELIGIBILITY


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:

- 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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Naomi Hunder, MD

Role: Study Director

Affiliation: Silverback Therapeutics

Overall Contact

Name: Naomi Hunder, MD

Phone: (206) 456-2900

Email: ClinOps@Silverbacktx.com

LOCATION

Facility Status Contact
Facility: Investigative Site
Boston, Massachusetts 02114
United States 		Status: Recruiting Contact: N/A
Facility: Investigative Site
Pittsburgh, Pennsylvania 15232
United States 		Status: Recruiting Contact: N/A
Facility: Investigative Site
Nashville, Tennessee 37203
United States 		Status: Recruiting Contact: N/A
Facility: Investigative Site
Houston, Texas 77030
United States 		Status: Recruiting Contact: N/A
Facility: Investigative Site
San Antonio, Texas 78229
United States 		Status: Recruiting Contact: N/A
Facility: Investigative Site
Sydney, New South Wales 2109
Australia 		Status: Recruiting Contact: N/A

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