Date: 2013-05-16
Type of information:
phase: 1
Announcement: presentation of pharmacokinetic data at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Vancouver, June 8-12, 2013
Company: Areva Med (France)
Product: ²¹²Pb-TCMC-Trastuzumab
Action mechanism: ²¹²Pb-TCMC-Trastuzumab is an experimental alpha radioimmunoconjugate. The candidate is the combination of a monoclonal antibody, trastuzumab, labeled with the radioisotope ²¹²Pb, through the use of a linker, TCMC. On one end, TCMC is stably attached to the antibody, on the other end it keeps the ²¹²Pb inside a cage specifically designed to hold the isotope. The TCMC linker is designed to ensure that the radioimmunoconjugate remains intact.
Disease: HER-2 positive intra-abdominal cancers
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The new trial (AREVAMED01) is an open label Phase 1, dose escalation study of ²¹²Pb-TCMC-Trastuzumab (©Genentech’s commercially approved Herceptin® antibody labeled with lead-212 or ²¹²Pb) in up to 36 patients and will be conducted at the University of Alabama at Birmingham (UAB) Comprehensive Cancer Center. The trial will evaluate the product’s toxicity profile, dose-limiting toxicities, and anti-tumor effects in patients with HER-2 positive intra-abdominal cancers. Each patient will be administered with a single intravenous injection trastuzumab (Herceptin®) followed by a single intraperitoneal injection of ²¹²Pb-TCMC-Trastuzumab. (NCT01384253)The principal investigator of the trial at the UAB is Ruby Meredith.
Latest
news: * On May 16, 2013, Areva Med has announced that it will present pharmacokinetics data on the company\'s ongoing Phase 1 clinical trial of its alpha radioimmunotherapy 212Pb-TCMC-Trastuzumab in patients with intra-abdominal cancers. The data will be presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Vancouver, June 8-12, 2013. Data will be presented on three patients with HER-2- expressing ovarian cancer who had failed standard therapies. 212Pb-TCMC-Trastuzumab was administered intraperitoneally after 4mg/kg intravenous trastuzumab.Objectives of the trial are safety, evaluation of plasma pharmacokinetics, human response, and anti-tumor effects. To date, six patients have been enrolled, and three of them have completed the six-month follow-up. After one year, the patients enter a period of long-term follow-up that includes quarterly visits for five years.
* On August 4, 2011, Areva Med has started a Phase 1 clinical trial in the United States for its new cancer treatment product. The Phase 1 trial being conducted at the University of Alabama at Birmingham (UAB) will allow researchers to study the behavior of the new product in patients and obtain initial information concerning its safety, effects and maximum dosages.
