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

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Silverback Therapeutics
• Treatments: Cemiplimab; Pembrolizumab

Criteria

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.