Stella Pharma announces that it has started the first patient trial for the domestic Phase I/II clinical trial that combines the [18F]FBPA-PET examination*1 and BNCT (Boron Neutron Capture Therapy) for patients with recurrent thoracic solid malignant tumors*2 that are refractory to standard treatment and unresectable, together with the National Cancer Center (NCC) (Tokyo), Sumitomo Heavy Industries, Ltd. (SHI, Tokyo), and CICS Inc. (Tokyo).
The trial is scheduled to begin with an [18F]FBPA-PET scan at the NCC Hospital.
The trial is the world’s first BNCT clinical trial targeting multiple cancers that occur in the thoracic region. By using the same normal tissues irradiated with neutrons, multiple cancers can be grouped together, which is expected to shorten the development period compared to conducting studies for each individual cancer. In addition, we expect that the pre-BNCT performed [18F] FBPA-PET will enable us to determine the suitability of BNCT before the procedure and to consider the most appropriate treatment for each patient.
The purpose of the trial is to evaluate the safety and efficacy of BNCT in patients with recurrent, unresectable, solid thoracic malignant tumors for which standard radiation therapy or chemotherapy is difficult to administer, and in which the lungs, heart, liver, spinal cord, and esophagus are common risk organs in those treatments. The trial will perform [18F] FBPA-PET on all patients prior to BNCT to evaluate the safety of [18F] FBPA.It also aims to conduct an exploratory evaluation of the usefulness of [18F] FBPA-PET in determining the appropriateness of BNCT. Target number of cases is 30. The trial is designed as Phase I/II, single-arm, open-label*3 study. The implementation period of the trial is from the date of the trial contract to October 31, 2028.
We will continue to work hard to deliver this new treatment option BNCT as soon as possible.
*1 [18F] FBPA-PET:
A PET test using [18F] FBPA (L-2-fluoro-4-boronophenylalanine) to measure the selective accumulation of the boron compound L-4-boronophenylalanine (BPA), used in BNCT, in the target tumor. The purpose of this examination is to confirm in advance, using imaging diagnosis, how much borofalan (10B) accumulates in cancer cells, which is necessary to target cancer cells in BNCT.
*2 Thoracic solid malignant tumors:
Esophageal cancer, non-small cell lung cancer, breast cancer, malignant soft tissue sarcoma occurring in thoracic areas, malignant pleural mesothelioma, etc.
*3 Open-label study
An open-label study is a study in which the subjects, the doctors and other medical personnel such as the data analysts know which treatment group the subjects have been assigned to.