Spots Global Cancer Trial Database for A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
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Trial Identification
Brief Title: A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
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
Study ID: NCT04460456
Conditions
Study Description
Brief Summary: A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
The START Center for Cancer Care, San Antonio, Texas, United States
Macquarie University Hospital Clinical Trials Unit, Sydney, New South Wales, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Breast Cancer Research Centre - WA, Nedlands, Western Australia, Australia
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: Naomi Hunder, MD
Affiliation: Silverback Therapeutics
Role: STUDY_DIRECTOR
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