論文

査読有り
2017年1月

LJM716 in Japanese patients with head and neck squamous cell carcinoma or HER2-overexpressing breast or gastric cancer

CANCER CHEMOTHERAPY AND PHARMACOLOGY
  • Shunji Takahashi
  • ,
  • Takayuki Kobayashi
  • ,
  • Junichi Tomomatsu
  • ,
  • Yoshinori Ito
  • ,
  • Hisanobu Oda
  • ,
  • Tatsuhiro Kajitani
  • ,
  • Tomoyuki Kakizume
  • ,
  • Takeshi Tajima
  • ,
  • Hiromi Takeuchi
  • ,
  • Heiko Maacke
  • ,
  • Taito Esaki

79
1
開始ページ
131
終了ページ
138
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1007/s00280-016-3214-4
出版者・発行元
SPRINGER

Human epidermal growth factor receptor 3 (HER3) has been identified as an important component of many receptor tyrosine kinase-driven cancers. LJM716 is a human IgG monoclonal antibody that binds HER3, trapping it in an inactive conformation. In this study, a phase I dose escalation was performed with a primary objective to establish the maximum tolerated dose and/or the recommended dose of LJM716 in Japanese patients with selected advanced solid tumors. Secondary objectives included the evaluation of the safety and tolerability, preliminary antitumor activity, and pharmacokinetics of LJM716 in Japanese patients.
LJM716 was administered intravenously at doses of 10, 20, or 40 mg/kg once weekly, in 28-day cycles, to 12 patients with HER2-amplified breast cancer or gastric cancer, or with esophageal squamous cell carcinoma or squamous cell carcinoma of the head and neck, regardless of HER2 status.
The maximum tolerated dose was not reached, and the recommended dose was established at 40 mg/kg. No dose-limiting toxicities were observed in the first cycle. The most frequently reported adverse events were diarrhea, fatigue, stomatitis, pyrexia, and paronychia. One unconfirmed partial response was observed in a patient with breast cancer, and 50% of the patients achieved stable disease as the best overall response. Exposure increased with ascending dose, and half-life was estimated to be 11-14 days. No anti-LJM716 antibodies were detected.
LJM716 was well tolerated in Japanese patients, and a degree of tumor shrinkage was observed.
ClinicalTrials.gov NCT01911936.

Web of Science ® 被引用回数 : 4

リンク情報
DOI
https://doi.org/10.1007/s00280-016-3214-4
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/27942917
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000392322700014&DestApp=WOS_CPL
ID情報
  • DOI : 10.1007/s00280-016-3214-4
  • ISSN : 0344-5704
  • eISSN : 1432-0843
  • PubMed ID : 27942917
  • Web of Science ID : WOS:000392322700014

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