Phase Ib Study On The Humanized Anti-Ccr4 Antibody, Kw-0761, In Advanced Solid Tumors

Takuro Saito, Koji Kurose, Takashi Kojima, Takeru Funakoshi, Eiichi Sato, Hiroyoshi Nishikawa, Jun Nakajima, Yasuyuki Seto, Kazuhiro Kakimi, Shinsuke Iida, Yuichiro Doki, Mikio Oka, Ryuzo Ueda, Hisashi Wada

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10 Citations (Scopus)


Tregs infiltrate tumors and inhibit antitumor immunity. KW-0761 (Mogamulizumab) is a humanized anti-CCR4 monoclonal antibody that could eliminate activated Tregs with high immunosuppressive activity that express CCR4. In this phase Ib trial, KW-0761 was used as a cancer immunotherapeutic reagent to deplete Tregs in patients with advanced or recurrent solid CCR4-negative tumors. Thirty-nine patients with solid cancer were treated with KW-0761 at a dose of 0.1 or 1.0 mg/kg. The safety, clinical responses, and effects of Treg depletion were analyzed. Any grade and grade 3–4 treatment-related adverse events (AEs) were observed in 36 (92%) and 14 (36%) out of 39 patients, respectively. All treatment-related AEs were manageable. One and 5 patients achieved a partial response and stable disease, respectively, during treatment and were long survivors. The efficient depletion of Treg in peripheral blood was confirmed in both cohorts. Therefore, the administration of KW-0761 was safe, resulting in the depletion of Tregs in peripheral blood and potential immune responses in patients with solid cancer.

Original languageEnglish
Pages (from-to)827-840
Number of pages14
JournalNagoya Journal of Medical Science
Issue number4
Publication statusPublished - 2021


  • CCR4
  • clinical trial
  • mogamulizumab
  • regulatory T cells
  • solid cancer patients

ASJC Scopus subject areas

  • Medicine(all)


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