A Study of SBT6050 in Patients With Advanced HER2 Expressing Solid Tumors

  • STATUS
    Recruiting
  • participants needed
    210
  • sponsor
    Silverback Therapeutics
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Updated on 16 February 2024
See if I qualify
cancer
measurable disease
solid tumour
pembrolizumab
solid tumor

Summary

A first-in-human (FIH) study using SBT6050 in HER2 expressing advanced malignancies

Description

This study has 2 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 advanced malignancies.

Details
Condition HER2 Positive Solid Tumors
Age 18years - 100years
Treatment SBT6050
Clinical Study IdentifierNCT04460456
SponsorSilverback Therapeutics
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) 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
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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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