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

Silverback Therapeutics58 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HER2 Positive Solid Tumors

Interventions

SBT6050DRUG

Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2

pembrolizumabDRUG

400 mg IV

CemiplimabDRUG

350 mg IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (12)

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke University

Durham, North Carolina, United States

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

The proportion of subjects experiencing dose limiting toxicities

Part 1 and 3 only

Time frame: 28 days

The incidence and severity of adverse events (AEs) and serious adverse events

Parts 1, 2, 3, 4, and 5

Time frame: 2 years

Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)

Parts 2, 4, and 5

Time frame: 2 years

Duration of response, defined as the time from date of first response (CR or PR)

Parts 2, 4, and 5

Time frame: 2 years

Secondary Outcomes

Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)

Parts1 and 3 only

Time frame: 2 years

Duration of response, defined as the time from date of first response (CR or PR)

Parts 1 and 3 only

Time frame: 2 years

Disease control rate, defined as CR, PR, or stable disease for at least 6 months

Parts 1, 2, 3, 4, and 5

Time frame: 2 years

Estimates of selected pharmacokinetics (PK ) parameters for SBT6050

Cmax: Parts 1, 2, 3, 4, and 5

Time frame: 2 years

Estimates of selected pharmacokinetics (PK ) parameters for SBT6050

Data from ClinicalTrials.gov

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