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.
Checked against the public recordLast updated Aug 18, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Silverback Therapeutics
- Interventions being studied
- Drug: SBT6050; Drug: trastuzumab deruxtecan; Drug: tucatinib; Drug: trastuzumab; Drug: capecitabine; Drug: trastuzumab deruxtecan
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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: 1. Breast cancer and colorectal cancer (CRC): archival biopsy tissue obtained after the last HER2-directed therapy (excluding trastuzumab and pertuzumab), or a fresh biopsy 2. 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Massachusetts General HospitalBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 18, 2022. Always confirm current availability with the study team.