Phase I/II clinical trial has been initiated in Japan for solid malignant thoracic tumors
April 15, 2025
Sumitomo Heavy Industries, Ltd. (Head Office: Shinagawa-ku, Tokyo; President and CEO: Shinji Shimomura; hereinafter the “Company”), the National Cancer Center Hospital, STELLA PHARMA CORPORATION (Head Office: Osaka-shi, Osaka; President and COO: Koki Uehara), and Cancer Intelligence Care Systems, Inc. (Head Office: Koto-ku, Tokyo; President and CEO: Tetsuya Furukawa) have already initiated Phase-I/II basket trials of the boron neutron capture therapy system (hereinafter “BNCT”) for patients for whom it is difficult to administer standard medical therapy and who have unresectable and recurrent thoracic malignant solid tumors (*1) (hereinafter "this clinical trial”). Sumitomo Heavy Industries, Ltd. hereby announces that the first patient of this clinical trial has been enrolled and the FBPA-PET imaging conducted.
This clinical trial is the first clinical trial of BNCT in the world that covers several types of thoracic cancer. It is expected that grouping several types of cancer can make the normal tissues irradiated by neutron beam common and shorten the development period in comparison with that of clinical trials for individual types of cancer. Through this clinical trial, it is expected that the suitability of BNCT by FBPA-PET (*2) will be determined prior to the procedure, enabling medical professionals to select the optimal treatment for each patient. The Company will continue development so that BNCT can satisfy unmet medical needs.
| Target | Patients whose organs at-risk are “lungs,” “hearts,” “livers,” “spinal cords,” and “esophagi” in BNCT treatment planning with therapeutic posture computed tomography (CT), and for whom it is difficult to administer standard radiation therapy and drug therapy and who have unresectable and recurrent thoracic malignant solid tumors |
| Purpose | 1) Evaluation of the safety and efficacy of BNCT 2) Evaluation of the safety of [18F]F-BPA by PET prior to BNCT 3) Exploratory evaluation about the efficacy of [18F]FBPA-PET imaging for the applicability of BNCT |
| Agreement period | From the date of signing the clinical trial agreement through October 31, 2028 |
| Details of the clinical trial | https://jrct.mhlw.go.jp/en-latest-detail/jRCT2031240246 |
(*1) Esophageal cancer, non-small-cell lung cancer, breast cancer, malignant soft tissue sarcoma in the thorax, malignant pleural mesothelioma, etc.
(*2) Positron emission tomography (PET) test with FBPA (2-fluoro-4-boronophenylalanine) to measure the amount of selectively accumulated boron in the target tumor of the boron compound for BNCT, L-4-boronophenylalanine (BPA)