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

  • STATUS
    Recruiting
  • End date
    Aug 15, 2024
  • participants needed
    344
  • sponsor
    Silverback Therapeutics
Updated on 15 January 2022

Summary

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

Description

This study has 5 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 4. Part 4 of the study will further evaluate SBT6050 in combination with pembrolizumab in select HER2 expressing or amplified advanced malignancies.

Part 5 of the study will evaluate the safety, tolerability, and activity of SBT6050 in combination with cemiplimab in select HER2 expressing or amplified advanced malignancies.

Details
Condition HER2 Positive Solid Tumors
Treatment Pembrolizumab, Cemiplimab, SBT6050, SBT6050 and pembrolizumab
Clinical Study IdentifierNCT04460456
SponsorSilverback Therapeutics
Last Modified on15 January 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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