WJOG18524G: a single-arm phase II study evaluating bemarituzumab combined with ramucirumab and paclitaxel in fibroblast growth factor receptor 2b (FGFR2b)-positive advanced gastric or gastroesophageal junction cancer (RAINBIRD)
The WJOG18524G trial (RAINBIRD) is a single-arm, multicenter phase II trial to evaluate the safety and efficacy of bemarituzumab in combination with paclitaxel plus ramucirumab in patients with FGFR2b-positive AGC who are intolerant or refractory to first-line fluoropyrimidine-based chemotherapy. The main inclusion criteria are unresectable or metastatic FGFR2b-positive gastric adenocarcinoma, refractoriness or intolerance to fluoropyrimidine-based chemotherapy, measurable lesions, and performance status of 0 or 1. The primary endpoint is the objective response rate, which is assessed by a blinded independent central review. Translational research is planned to explore the predictive biomarkers and mechanisms of resistance to bemarituzumab by sequencing tumor DNA (PleSSiSion-Neo) and circulating tumor DNA (Guardant360), which are collected at multiple time points.
Authors
- Hisato Kawakami (ORCID: https://orcid.org/0000-0002-3280-4850)
- Narikazu Boku (ORCID: https://orcid.org/0000-0002-1438-707X)
- Wataru Okamoto (ORCID: https://orcid.org/0000-0002-2602-7282)
- Kenro Hirata (ORCID: https://orcid.org/0000-0003-4536-7781)
- Yasunori Sato (ORCID: https://orcid.org/0000-0002-7189-5126)
- Masato Komoda (ORCID: https://orcid.org/0009-0009-5901-323X)
- Yukiya Narita (ORCID: https://orcid.org/0000-0002-8018-0077)
- Keitaro Shimozaki (ORCID: https://orcid.org/0000-0002-4559-5699)
- N. Takegawa (ORCID: https://orcid.org/0000-0002-2574-8950)
- T. Ando
- Yoshito Komatsu (ORCID: https://orcid.org/0000-0002-1570-6802)
- Shin‐ichi Taniguchi (ORCID: https://orcid.org/0000-0002-1417-8753)
- Akitaka Makiyama (ORCID: https://orcid.org/0000-0002-4017-668X)
- Naoki Takahashi (ORCID: https://orcid.org/0000-0001-6377-9507)
- Kei Muro (ORCID: https://orcid.org/0000-0002-5572-743X)
- Hideyuki Hayashi (ORCID: https://orcid.org/0000-0002-4974-8015)
- Mitsuhiro Furuta (ORCID: https://orcid.org/0000-0003-4706-2615)
- K. Yamazaki
- T. Kawakami
- Seiichiro Mitani (ORCID: https://orcid.org/0000-0003-0033-8741)
- Tomohiro Nishina (ORCID: https://orcid.org/0000-0002-4073-3757)
- Kensei Yamaguchi (ORCID: https://orcid.org/0000-0001-6887-5709)
- Takatsugu Ogata (ORCID: https://orcid.org/0000-0003-1059-5215)
- A. Hosokawa
Institutions
- Tokyo University of Science (JP)
- Keio University (JP)
- National Kyushu Medical Center (JP)
- Kanagawa Prefectural Hospital Organization (JP)
- Shizuoka Cancer Center (JP)
- National Hospital Organization Kyushu Cancer Center (JP)
- Tohoku University Hospital (JP)
- Gifu University Hospital (JP)
- Saitama Cancer Center (JP)
- Hiroshima University Hospital (JP)
- Aichi Cancer Center (JP)
- University of Miyazaki Hospital (JP)
- Shikoku Cancer Center (JP)
- Hokkaido University Hospital (JP)
- Osaka International Cancer Institute (JP)
- Hyogo Prefectural Cancer Center (JP)
- Japanese Foundation For Cancer Research (JP)
- University of Toyama (JP)
- Kindai University (JP)
Publication Details
- Journal
- ESMO Gastrointestinal Oncology
- Published
- 2025-06-09
- DOI
- https://doi.org/10.1016/j.esmogo.2025.100189
- Citations
- 1
- Primary Topic
- Fibroblast Growth Factor Research
- Type
- article
- Field-Weighted Citation Impact
- 0.81