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Trastuzumab conjugated to N-succinyldesferrioxamine B-tetrafluorphenol and radiolabeled with zirconium (89Zr) is an investigational imaging agent. It combines the HER2-targeting antibody trastuzumab with a radioactive tracer, zirconium-89, allowing HER2-positive tumours to be visualised with PET/CT scans.
Trastuzumab is a targeted cancer drug, also known by the trade names Herceptin, Herzuma and Ontruzant.[4] It is a humanised IgG1 monoclonal antibody produced by mammalian cell culture.[5] The radiolabelled form, 89Zr-trastuzumab, is an investigational imaging agent used in clinical trials to visualise HER2 expression in tumours. Trastuzumab is classified as an antineoplastic agent, monoclonal antibody (ATC code L01XC03).[5] The substance is already authorised as a medicine for treating HER2-positive breast cancer and gastric cancer.[4]
Trastuzumab works by locking onto a protein called human epidermal growth factor receptor 2 (HER2) on cancer cells.[4] HER2 makes cells grow and divide, and some breast and stomach cancers have large amounts of it. By attaching to HER2, trastuzumab aims to stop the cancer cells from growing and to kill them.[4] The radiolabelled version, 89Zr-trastuzumab, uses this same targeting mechanism but carries zirconium-89, which emits radiation detectable by PET/CT imaging. This allows researchers to see where HER2-positive tumour cells are located in the body.
Trastuzumab is given either as a drip into the bloodstream (intravenously) or as an injection under the skin (subcutaneously).[4] Intravenous treatment takes between 30 and 90 minutes, with the first treatment given over 90 minutes.[4] In the clinical trials, 89Zr-trastuzumab is given intravenously at doses of 37 to 40.7 MBq (megabecquerels).[1][2] Trastuzumab is available as a powder for concentrate for solution for infusion in 150 mg, 420 mg, 100 mg and 160 mg strengths.[3][5]
Three clinical trial records investigate 89Zr-trastuzumab in HER2-positive breast cancer, all Phase 2 interventional studies.[1][1][2] The trials aim to assess whether HER2 PET/CT imaging with 89Zr-trastuzumab can predict response to antibody-drug conjugate therapies such as trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd).
The primary outcome measures include characterisation of genomic alterations and HER2 expression, time to treatment failure (TTF) defined as the time from T-DM1 start to discontinuation for any reason, and metabolic objective response rate (ORR) assessed by PERCIST 1.0 after 3 cycles of T-DXd.[1][1][2] Participants are patients with advanced or metastatic HER2-positive breast cancer who have received at least one line of systemic therapy, or those eligible for T-DXd according to local approval.
Trastuzumab can cause side effects, and the healthcare team checks for these during the first infusion.[4] The sources provided do not list specific common or serious side effects in detail. Trastuzumab only works in cancers that are HER2 positive, and tests are done on cancer cells to check for this.[4]
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