An open-label phase Ib/II study of trastuzumab deruxtecan combined with nivolumab and CAPOX for HER2-low gastroesophageal adenocarcinoma
EPOC2203 is a single-arm, phase Ib/II study evaluating the efficacy and safety of T-DXd combined with nivolumab and reduced-dose CAPOX as first-line treatment of patients with HER2-low mGEA. Phase Ib uses the traditional 3 + 3 design to determine the recommended phase II dose (RP2D). Patients will receive T-DXd (5.4 mg/kg, day 1) combined with nivolumab (360 mg/body, day 1) and CAPOX (capecitabine: 750 mg/m<sup>2</sup> twice daily, days 1-14 and oxaliplatin: 70 mg/m<sup>2</sup>, day 1), every 3 weeks. The primary endpoints are the dose-limiting toxicity rate in phase Ib and the objective response rate (ORR) in phase II. Hypothesis testing assumes a null ORR of 58% and an alternative ORR of 80%. The planned sample size is 28 patients treated with RP2D.
Authors
- Naoya Sakamoto (ORCID: https://orcid.org/0000-0001-6273-0189)
- K. Shitara
- Hirokazu Shoji (ORCID: https://orcid.org/0000-0002-8922-5227)
- M. Furuta
- Hiroki Hara
- Nozomu Fuse (ORCID: https://orcid.org/0000-0002-7123-0167)
- S. Fukuoka
- Takeshi Kuwata (ORCID: https://orcid.org/0000-0003-0044-953X)
- Izuma Nakayama (ORCID: https://orcid.org/0000-0003-4987-1934)
- Keiko Minashi (ORCID: https://orcid.org/0000-0003-1513-7117)
- Masashi Wakabayashi (ORCID: https://orcid.org/0009-0001-6368-5671)
- Atsushi Satō (ORCID: https://orcid.org/0000-0002-5417-6701)
- Y Komura
- Yoshihiko Aoki
Institutions
- Kanagawa Prefectural Hospital Organization (JP)
- Chiba Cancer Center (JP)
- Saitama Cancer Center (JP)
- Saiseikai Central Hospital (JP)
- National Cancer Center Hospital East (JP)
- Japanese Foundation For Cancer Research (JP)
- Kanagawa Cancer Center
Publication Details
- Journal
- ESMO Gastrointestinal Oncology
- Published
- 2025-09-01
- DOI
- https://doi.org/10.1016/j.esmogo.2025.100207
- Primary Topic
- Gastric Cancer Management and Outcomes
- Type
- article
- Field-Weighted Citation Impact
- 0.00