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

HER2 Positive Solid Tumors Clinical Trial

Official title:

A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced Solid Tumors Expressing HER2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04460456
• Other study ID #: SBT6050-101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 27, 2020
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: Silverback Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HER2 Positive Solid Tumors
• Neoplasms

Intervention

Drug:
• SBT6050
Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
• pembrolizumab
400 mg IV
• Cemiplimab
350 mg IV

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Breast Cancer Research Centre - WA	Nedlands	Western Australia
Australia	Macquarie University Hospital Clinical Trials Unit	Sydney	New South Wales
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke University	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute/Tennessee Oncology	Nashville	Tennessee
United States	University of Pittsburgh Medical Center Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	The START Center for Cancer Care	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Silverback Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects experiencing dose limiting toxicities	Part 1 and 3 only	28 days
Primary	The incidence and severity of adverse events (AEs) and serious adverse events	Parts 1, 2, 3, 4, and 5	2 years
Primary	Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)	Parts 2, 4, and 5	2 years
Primary	Duration of response, defined as the time from date of first response (CR or PR)	Parts 2, 4, and 5	2 years
Secondary	Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)	Parts1 and 3 only	2 years
Secondary	Duration of response, defined as the time from date of first response (CR or PR)	Parts 1 and 3 only	2 years
Secondary	Disease control rate, defined as CR, PR, or stable disease for at least 6 months	Parts 1, 2, 3, 4, and 5	2 years
Secondary	Estimates of selected pharmacokinetics (PK ) parameters for SBT6050	Cmax: Parts 1, 2, 3, 4, and 5	2 years
Secondary	Estimates of selected pharmacokinetics (PK ) parameters for SBT6050	AUC: Parts 1, 2, 3, 4, and 5	2 years
Secondary	Incidence of antidrug antibodies (ADA) to SBT6050	Parts 1 and 2	2 years
Secondary	Progression free survival	Parts 2, 4, and 5	2 years