A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
NCT ID: NCT05091528
Last Updated: 2022-08-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
2 participants
INTERVENTIONAL
2022-02-08
2022-07-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tucatinib+Trastuzumab+Eribulin in HER2+ MBC
NCT05458674
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
NCT04460456
A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
NCT02149524
Phase 1, Multiple Ascending Dose Study of Anti-HER2 FCAB FS102 in HER2 Positive Solid Tumors (Anti HER2 Fcab)
NCT02286219
Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin in Patients With Solid Tumors and Her2 Positive Metastatic Breast Cancer That Have Previously Failed Herceptin
NCT00773344
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SBT6050 + T-DXd (5.4 mg/kg)
SBT6050 plus trastuzumab deruxtecan
SBT6050
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles
trastuzumab deruxtecan
5.4 mg/kg by intravenous (IV) infusion in 21-day cycles
SBT6050 + T-DXd (6.4 mg/kg)
SBT6050 plus trastuzumab deruxtecan
SBT6050
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles
trastuzumab deruxtecan
6.4 mg/kg by IV infusion in 21-day cycles
SBT6050 + Tucatinib + Trastuzumab + Capecitabine
SBT6050 plus tucatinib, trastuzumab, and capecitabine
SBT6050
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles
tucatinib
300 mg by mouth (PO) twice daily (BID)
trastuzumab
8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
capecitabine
1000 mg/m2 PO BID for 14 days of each 21-day cycle
SBT6050 + Tucatinib + Trastuzumab
SBT6050 plus tucatinib and trastuzumab
SBT6050
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles
tucatinib
300 mg by mouth (PO) twice daily (BID)
trastuzumab
8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SBT6050
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles
trastuzumab deruxtecan
5.4 mg/kg by intravenous (IV) infusion in 21-day cycles
tucatinib
300 mg by mouth (PO) twice daily (BID)
trastuzumab
8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
capecitabine
1000 mg/m2 PO BID for 14 days of each 21-day cycle
trastuzumab deruxtecan
6.4 mg/kg by IV infusion in 21-day cycles
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Silverback Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Naomi Hunder, MD
Role: STUDY_DIRECTOR
Silverback Therapeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SBT6050-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.