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

Silverback Therapeutics

Status and phase: Active, not recruiting; Phase 1

Conditions: HER2 Positive Solid Tumors

Treatments: Drug: SBT6050; Drug: Cemiplimab; Drug: pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04460456

SBT6050-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 3 patient groups

SBT6050 Monotherapy

Experimental group

Description:

Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.

Treatment:

Drug: SBT6050

SBT6050 and pembrolizumab

Experimental group

Description:

Escalating doses of SBT6050 in combination with pembrolizumab in Part 3 followed by expansion in Part 4 at the recommended dose determined in Part 3.

Treatment:

Drug: pembrolizumab

Drug: SBT6050

SBT6050 and cemiplimab

Experimental group

Description:

SBT6050 in combination with cemiplimab in Part 5 at the recommended dose determined in Parts 1 and 3.

Treatment:

Drug: Cemiplimab

Drug: SBT6050