Breast Cancer Clinical Trial
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
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.
Eligibility Criteria
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
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There is 1 Location for this study
Boston Massachusetts, 02114, United States
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