NCT04215159

Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Solid Tumor

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Jin-Hee Ahn · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HER-2 Protein Overexpression
• HER-2 Gene Amplification

Interventions

Type	Name	Description
DRUG	Trastuzumab biosimilar	1st cycle 8 mg/kg by IV infusion over 90 mins, from 2nd cycle 6mg/kg by IV infusion over 30 mins. every 3weeks.
DRUG	Gemcitabine Hydrochloride	1000 mg/m2 by IV infusion over 30 minutes on Day 1, Day 8. every 3weeks.
DRUG	Irinotecan Hydrochloride	100 mg/m2 by IV infusion over 90 minutes on Day 1, Day 8. every 3weeks.

Timeline

• Start date: 2019-12-30
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2020-01-02
• Last updated: 2020-01-02