Sumitomo Heavy Industries Ltd.

09/03/2024 | Press release | Distributed by Public on 09/02/2024 19:08

Signed agreement for the Clinical Trial of BNCT with National Cancer Center, STELLA PHARMA and CICS

September 03, 2024

Sumitomo Heavy Industries, Ltd. (Head Office: Shinagawa-ku, Tokyo; President and CEO: Shinji Shimomura) signed the agreement with the National Research and Development Agency, National Cancer Center Japan (Head Office: Chuo-ku, Tokyo; President: Hitoshi Nakagama), 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: Tetsuya Furukawa) about Phase-I/II basket trials of the boron neutron capture therapy system (hereinafter "BNCT") for patients for whom it is difficult to provide with a standard therapy and have unresectable and recurrent thoracic malignant solid tumors (*1) (hereinafter "this clinical trial").

This clinical trial is the first clinical trial of BNCT in the world that covers several types of thoracic cancer.
We expect that grouping several types of cancer can make the normal tissues neutron irradiated common and shorten the development period in comparison with that of clinical trials for individual types of cancer.
At present, when a thoracic malignant tumor has been treated with standard therapy in the initial treatment, only drug therapy is selected for recurrence with no local therapy option. Through this clinical trial, we also expect judgment of applicability for BNCT with FBPA-PET (*2) before treatment enables consideration of optimal therapy for patients.

We will continue development so that BNCT can satisfy unmet medical needs.

[Outline of this clinical trial]
Target Patients who are not applicable for standard radiation therapy and/or drug therapy that have the same organs at risk as BNCT at treatment plan based on X-CT (Xray computed tomography) with treatment posture, and have unresectable and recurrent thoracic malignant solid tumors. The organs at risk are "lungs", "heart", "liver", "spinal cord", and "esophagus".
Purpose 1) Safety and efficacy evaluation of BNCT
2) Safety evaluation of [18F]F-BPA PET imaging before BNCT for all participants
3) Exploratory evaluation about usefulness of judging applicability for BNCT by [18F]FBPA-PET imaging
Facility National Cancer Center
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
Agreement period Until October 31, 2028
Details of the clinical trial https://jrct.niph.go.jp/latest-detail/jRCT2031240246 (Japanese version only)

(*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) imaging to measure the amount of boron selectively accumulated in the target tumor delivered by the boron compound L-4-boronophenylalanine (BPA). FBPA(2-fluor-4-boronophenylalanine) is used.