HER-2 Protein Overexpression Clinical Trial
Official title:
Prospective Phase II Study to Investigate the Efficacy and Safety of Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Solid Tumor
HER2 signaling pathway abnormalities or HER2 overexpression can be seen in various types of
solid tumors apart from breast cancer or hepatic cancer. In this regardHER2 targeting therapy
has been proven to be effective in colorectal cancer, gallbladder cancer, and salivary gland
tumors. Although HER2 targeted-treatment Trastuzumab biosimilar is clinically being used
after gaining official permission recently, clinical data for this use is still lacking,
especially regarding experiences of combination with various cytotoxic chemotherapy agents.
Notably, techniques to separate and extract a small sized ciculating tumor DNA (ctDNA) in
patient's blood originated from a tumor is being developed and improved along with
introduction of Next-generation sequencing (NGS) technique enabling a comprehensive genetic
testing.
The aim of this study is to evaluate the efficacy and safety of Trastuzumab biosimiler and to
investigate the association between ctDNA and clinical outcomes such as disease response,
progression-free survival, and overall survival.
Samfenet is a biosimilar of trastuzumab and received marketing approval based on the results
of efficacy equivalence to trastuzumab. This study is a phase 2 study to investigate the
efficacy of Samfenet in combination with cytotoxic agents in patients with HER2-positive
solid tumors.
A total of 42 patients will be enrolled. Treatment will be continues until disease
progression, unacceptable toxicity or patient withdrawal. Tumor evaluation will be performed
at every 8 weeks during treatment, and then at every 12 weeks thereafter end of study.
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