We would like to announce that our company submitted the trial plan notification for a domestic phase I/II clinical trial targeting unresectable and recurrent thoracic solid malignant tumor※１ that is difficult to treat with standard therapies. The trial combines FBPA-PET※２ and BNCT (Boron Neutron Capture Therapy) and the trial plan notification was submitted to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
After a 30 days investigation period※３ of the PMDA and the evaluation of the Institutional Review Board, the enrollment of participants and execution of clinical trial procedure will start, in accordance with the contract concluded with the trial site.
Phase I/II Trial Overview – Thoracic Malignant Tumor
| Purpose | Safety and efficacy evaluation of BNCT in patients with unresectable tumors in organs at risk, such as the lungs, heart, liver, spinal cord, and esophagus, that are difficult to treat with standard radiation therapy or chemotherapy. Evaluation of safety for [18F]FBPA. Exploratory evaluation of the potential of [18F] FBPA-PET scans for determining whether or not to perform BNCT. |
| Target number of participants | 30 participants |
| Study design | Phase I/II, single-arm, open-label |
| Study period | From signing date of clinical trial agreement until October 31st, 2028 |
※１ thoracic solid malignant tumors:
Esophageal cancer, non-small cell lung cancer, breast cancer, malignant soft tissue sarcoma
occurring in thoracic area, malignant pleural mesothelioma, etc.
※２ FBPA-PET:
A PET test using FBPA (2-fluoro-4-boronophenylalanine) to measure the selective accumulation of
the boron compound L-4-boronophenylalanine (BPA), used in BNCT, in the target tumor.
※３ 30 days investigation period:
In the first clinical trial, a trial sponsor or the investigator himself can start the trial only 30 days
after the notification to the Ministry of Health, Labor and Welfare (quoted from the PMDA website).