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Monoclonal Antibodies

SBT6050 for Breast cancer

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 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Awards & 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
~11 spots leftby Nov 2025
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