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

Sarah Cannon Research Institute/Tennessee Oncology

Nashville, Tennessee, United States

Duke University Medical Center

Durham, North Carolina, United States


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