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Monoclonal Antibodies
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by Silverback Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, SBT6050, alone and with other drugs in patients with advanced HER2-positive cancers. SBT6050 targets cancer cells directly, while the other drugs help the immune system fight the cancer.
Eligible Conditions
- Breast cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The incidence and severity of adverse events (AEs) and serious adverse events
The proportion of subjects experiencing dose limiting toxicities
Secondary study objectives
Disease control rate, defined as CR, PR, or stable disease for at least 6 months
Duration of response, defined as the time from date of first response (CR or PR)
Estimates of selected pharmacokinetics (PK ) parameters for SBT6050
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: SBT6050 and pembrolizumabExperimental Treatment2 Interventions
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.
Group II: SBT6050 and cemiplimabExperimental Treatment2 Interventions
SBT6050 in combination with cemiplimab in Part 5 at the recommended dose determined in Parts 1 and 3.
Group III: SBT6050 MonotherapyExperimental Treatment1 Intervention
Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1470
pembrolizumab
2017
Completed Phase 3
~5890
Find a Location
Who is running the clinical trial?
Silverback TherapeuticsLead Sponsor
2 Previous Clinical Trials
2 Total Patients Enrolled
Naomi Hunder, MDStudy DirectorSilverback Therapeutics
4 Previous Clinical Trials
157 Total Patients Enrolled