For Healthcare Professionals

A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors

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About the study

A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) or amplified solid tumor
  2. Subjects must have received prior therapies known to confer clinical benefit (unless ineligible or refused to receive)
  3. Measurable disease per RECIST 1.1
  4. Tumor lesion amenable for biopsy or able to provide tissue from biopsy within last 6 months
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Adequate hematologic, hepatic, and cardiac function

EXCLUSION CRITERIA

Exclusion Criteria:


  1. History of allergic reactions to certain components of SBT6050 or similar drugs
  2. Untreated brain metastases
  3. Active autoimmune disease or a documented history of autoimmune disease or syndrome
  4. Human immunodeficiency virus infection, active hepatitis B infection or hepatitis C infection
  5. Additional protocol defined inclusion/exclusion criteria may apply.


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

HER2 Positive Solid Tumors

Age (in years)

18+

Phase

Phase 1

Participants needed

58

Est. Completion Date

Dec 31, 2022

Treatment type

Interventional


Sponsor

Silverback Therapeutics

ClinicalTrials.gov identifier

NCT04460456

Study number

SBT6050-101

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