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

Sponsor
Jin-Hee Ahn
Study ID
NCT04215159
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
19 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 30, 2019
Status verified
Dec 2019
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Samfenet and Treatment of physician's choice
    * Samfenet : 1st cycle 8 mg/kg by IV infusion over 90 mins, from 2nd cycle 6mg/kg by IV infusion over 30 mins. every 3weeks. * Treatment of physician's choice (Gemcitabine or Irinotecan) 1. Gemcitabine : 1000 mg/m2 by IV infusion over 30 minutes on Day 1, Day 8. every 3weeks. 2. Irinotecan : 100 mg/m2 by IV infusion over 90 minutes on Day 1, Day 8. every 3weeks.

Primary Outcome Measure

objective response rate [ Time Frame: 8 weeks ]

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