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Monoclonal Antibodies

SBT6050 + T-DXd (5.4 mg/kg) for Breast Cancer

Phase 1 & 2
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 21 days
Awards & highlights

Study Summary

This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2). Participants will be enrolled into each Arm based on cancer diagnosis and prior therapies.

Eligible Conditions
  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • Gastric Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Laboratory Abnormalities
Proportion of Participants With Dose Limiting Toxicities
Secondary outcome measures
Duration of Response for Participants With an Objective Response Rate
Number of Participants With Treatment-emergent Adverse Events
Number of Participants With an Objective Response Rate
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: SBT6050 + Tucatinib + Trastuzumab + CapecitabineExperimental Treatment4 Interventions
SBT6050 plus tucatinib, trastuzumab, and capecitabine
Group II: SBT6050 + Tucatinib + TrastuzumabExperimental Treatment3 Interventions
SBT6050 plus tucatinib and trastuzumab
Group III: SBT6050 + T-DXd (6.4 mg/kg)Experimental Treatment2 Interventions
SBT6050 plus trastuzumab deruxtecan
Group IV: SBT6050 + T-DXd (5.4 mg/kg)Experimental Treatment2 Interventions
SBT6050 plus trastuzumab deruxtecan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tucatinib
2018
Completed Phase 2
~800
trastuzumab
2002
Completed Phase 3
~1790
capecitabine
2002
Completed Phase 3
~2360

Find a Location

Who is running the clinical trial?

Silverback TherapeuticsLead Sponsor
2 Previous Clinical Trials
58 Total Patients Enrolled
Vinona Bhatia, MD, MPHStudy DirectorSilverback Therapeutics, Inc.
Naomi Hunder, MDStudy DirectorSilverback Therapeutics, Inc.
4 Previous Clinical Trials
213 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Indiana
Arizona
Other
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
2022. "A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05091528.
~1 spots leftby Apr 2025
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