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UnknownPhase 1NCT04460456
Official study title

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

Study summary

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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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSBT6050 and pembrolizumab

Plus 1 other study approaches.

Who it may be forHER2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 30, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?12 U.S. locations

Locations may change over time.

Who runs it?Silverback Therapeutics

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Silverback Therapeutics
Interventions being studied
Drug: SBT6050; Drug: pembrolizumab; Drug: Cemiplimab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
HER2→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Massachusetts General HospitalBoston, Massachusetts
  • Duke UniversityDurham, North Carolina
  • University of Pittsburgh Medical Center Hillman Cancer CenterPittsburgh, Pennsylvania
  • Sarah Cannon Research Institute/Tennessee OncologyNashville, Tennessee
  • MD Anderson Cancer CenterHouston, Texas
  • The START Center for Cancer CareSan Antonio, Texas
  • Macquarie University Hospital Clinical Trials UnitSydney, New South Wales
  • Peter MacCallum Cancer CentreMelbourne, Victoria
  • Breast Cancer Research Centre - WANedlands, Western Australia
  • Seoul National University HospitalSeoul
  • Asan Medical CenterSeoul
  • Samsung Medical CenterSeoul

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 30, 2022. Always confirm current availability with the study team.

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