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. 2022 Jun;18(19):2351-2360.
doi: 10.2217/fon-2022-0214. Epub 2022 May 5.

Multicenter phase II trial of trastuzumab deruxtecan for HER2-positive unresectable or recurrent biliary tract cancer: HERB trial

Akihiro Ohba  1 , Chigusa Morizane  1 , Makoto Ueno  2 , Satoshi Kobayashi  2 , Yasuyuki Kawamoto  3 , Yoshito Komatsu  4 , Masafumi Ikeda  5 , Mitsuhito Sasaki  5 , Naohiro Okano  6 , Junji Furuse  6 , Nobuyoshi Hiraoka  7 , Hiroshi Yoshida  7 , Aya Kuchiba  8 , Ryo Sadachi  8 , Kenichi Nakamura  9 , Naoko Matsui  9 , Yoshiaki Nakamura  10 , Wataru Okamoto  11 , Takayuki Yoshino  10 , Takuji Okusaka  1
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Free article

Multicenter phase II trial of trastuzumab deruxtecan for HER2-positive unresectable or recurrent biliary tract cancer: HERB trial

Akihiro Ohba et al. Future Oncol. 2022 Jun.
Free article

Abstract

Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate composed of a humanized monoclonal anti-HER2 antibody, a cleavable tetrapeptide-based linker and a potent topoisomerase I inhibitor. The drug's efficacy has been proven in HER2-positive breast and gastric cancers. The rate of HER2 positivity in biliary tract cancer (BTC) has been reported to be 5-20%, and case reports and clinical trials have suggested that HER2 inhibitors might be active in HER2-positive BTC. Here we describe the rationale and design of the phase II HERB trial that will evaluate the efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing unresectable or recurrent BTC. The primary end point will be the centrally assessed objective response rate in HER2-positive patients.

Keywords: DS-8201; HER2; HER2-positive; antibody–drug conjugate; biliary tract cancer; circulating tumor DNA; investigator-initiated registration-directed trial; trastuzumab deruxtecan.

Plain language summary

Trastuzumab deruxtecan (DS-8201) is a new drug against HER2, a receptor on cell membranes that has sensitivity to targeted inhibitors. The drug’s efficacy has been proven in HER2-positive breast and gastric cancers. Some studies have suggested that HER2 inhibitors might be active in HER2-positive biliary tract cancers. This article describes the design of a new clinical trial. The HERB trial is designed to evaluate the efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing biliary tract cancers. Clinical trial registration: JMA-IIA00423.

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