Phase i study of amatuximab, a novel monoclonal antibody to mesothelin, in Japanese patients with advanced solid tumors

Yasuhito Fujisaka, Takayasu Kurata, Kaoru Tanaka, Toshihiro Kudo, Kunio Okamoto, Junji Tsurutani, Hiroyasu Kaneda, Isamu Okamoto, Masayuki Namiki, Chifumi Kitamura, Kazuhiko Nakagawa

Research output: Contribution to journalArticlepeer-review

21 Citations (Scopus)

Abstract

Amatuximab is a chimeric monoclonal antibody that targets mesothelin, which is expressed in virtually all mesotheliomas and pancreatic adenocarcinomas. The objective of this study was to determine the dose-limiting toxicity and the maximum tolerated dose. Patients with mesothelioma, pancreatic adenocarcinoma or other mesothelin-positive solid tumors were eligible for this study. Amatuximab was administered weekly as an intravenous infusion in 4-week cycles at progressively increasing doses ranging from 50 to 200 mg/m2. Seventeen patients received amatuximab. Two dose-limiting toxicities were observed: one at 50 mg/m2 and one at 200 mg/m2; the maximum tolerated dose of this study was determined to be 200 mg/m2. Of the 17 patients, 13 patients (76.5 %) experienced treatment-related adverse events. The most common adverse events were grade 1 fatigue (29.4 %) and pyrexia (23.5 %). The maximum serum concentration and area under the concentration curve values increased in an almost dose-proportional manner. Three patients had stable disease. Amatuximab was generally well tolerated at doses up to 200 mg/m2. The pharmacokinetic profile of amatuximab in the Japanese population was similar to that seen in the United States population (Clinical Trials.gov Identifier: NCT01018784).

Original languageEnglish
Pages (from-to)380-388
Number of pages9
JournalInvestigational New Drugs
Volume33
Issue number2
DOIs
Publication statusPublished - Apr 1 2015

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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