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

Status unconfirmed · Phase 1

Conditions studied: HER2 Positive Solid Tumors

In brief

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

Key facts

Study ID

NCT04460456

Run by

Silverback Therapeutics

People needed

58

Starts

2020-07-27

Expected to finish

2022-12-01

Last updated by the study team

2022-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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