Oncology Clinical Trial Finder
Breast Cancer

Terminated • Phase I, II • Stage III, IV • Medical Oncology • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

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.

Breast Cancer

Study Design
Study type:


Estimated enrollment:

2 participant

Actual study start date:

February 8, 2022

Eligibility Criteria
Ages eligible for study:

18 - 999

Sexes eligible for study:


Arms and Intervention
  • SBT6050

  • trastuzumab deruxtecan

  • tucatinib

  • trastuzumab

  • capecitabine

  • trastuzumab deruxtecan

Inclusion criteria
  • advanced or metastatic her2-expressing (ihc 2+ or 3+) or her2-amplified solid tumors

  • measurable disease per the the response evaluation criteria in solid tumors (recist) version 1.1 criteria

  • tumor lesion amenable for biopsy or able to submit an adequate recent archived tumor tissue for baseline testing, as follows:

  • breast cancer and colorectal cancer (crc): archival biopsy tissue obtained after the last her2-directed therapy (excluding trastuzumab and pertuzumab), or a fresh biopsy

  • gastric cancer and non-small-cell lung cancer (nsclc): archival biopsy tissue taken within the past 12 months and after completion of last her2-directed therapy, or a fresh biopsy

  • ecog performance status of 0 or 1

  • adequate hematologic, hepatic, renal, and cardiac function

Exclusion criteria
  • history of allergic reactions to certain components of study treatment therapies

  • untreated brain metastases

  • currently active (or history of) autoimmune disease

  • taking the equivalent of >10 mg / day of prednisone

  • taking a medication that moderately induces cyp2c, strongly inhibits cyp2c8, or interacts with both enzymes (cyp3a and cyp2c8)

  • uncontrolled or clinically significant interstitial lung disease (ild) / pneumonitis that requires systemic corticosteroid treatment or suspected ild / pneumonitis

  • hiv infection, active hepatitis b or hepatitis c infection

Trial Information at Site
Last Updated:
Trial Information
ClinicalTrial.gov ID:


Estimated Enrollment:


Last Updated:


Principal Investigator

Naomi Hunder, MD

Trial Sponsor

Silverback Therapeutics

Study Location (4)

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

Sarah Cannon Research Institute/Tennessee Oncology

Nashville, Tennessee, United States


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