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 19 February 2024

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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 Identifier	NCT04460456
Sponsor	Silverback Therapeutics
Last Modified on	19 February 2024

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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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Study Definition

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