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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

Study Summary

This trial is testing a new cancer treatment, SBT6050, on humans for the first time. The trial is testing SBT6050 alone and in combination with another cancer treatment, PD-1 inhibitors, in people with HER2 expressing or amplified advanced malignancies.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence and severity of adverse events (AEs) and serious adverse events
The proportion of subjects experiencing dose limiting toxicities
Secondary outcome measures
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

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
~1340
pembrolizumab
2017
Completed Phase 3
~5750

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
2020. "A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04460456.
~12 spots leftby Apr 2025
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