Domestic Phase I/II Trial Toward Expanding BNCT Indications to Thoracic Malignancies
First written in FY2025-H1. 6 of 7 entries say "Advanced", first in FY2026-H1. Latest entry: FY2026.
1 other company's latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「Esophageal cancer, one of the diseases targeted by the clinical trial, was selected for AMED’s FY2026 “Drug Discovery Support Promotion Project and Pre-designation Practical Application Support Project for Orphan Drugs,” and we will receive development support for a boron drug for BNCT targeting unresectable, advanced or recurrent esophageal cancer. We are now eligible to receive a subsidy of up to approximately ¥280 million over the 3-year period from 1 April 2026 to 31 March 2029.」
For the Phase I/II trial for thoracic malignancies, the esophageal cancer development project was selected by AMED, advancing to the stage of receiving a subsidy of up to approximately ¥280 million from April 2026 to March 2029. - FY2026-H1AdvancedAnnual report
「To expand the indication of SPM-011 to thoracic malignancies, we began treating the first patient in the Phase I/II clinical trial in April 2025. The clinical trial is scheduled to continue through October 2028.」
The first patient was enrolled in the Phase I/II basket trial for thoracic malignancies in April 2025, and the clinical trial is scheduled to continue through October 2028. - FY2025-H1First statedAnnual report
「We submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency for a domestic Phase I/II clinical trial combining 18F-FBPA-PET and BNCT in patients with unresectable recurrent thoracic malignancies for whom standard treatment is difficult to administer, and in September 2024 entered into an agreement concerning the conduct of the clinical trial with the National Cancer Center Japan, SHI and CICS Co., Ltd.」
For a basket clinical trial covering multiple thoracic cancer types, including recurrent breast cancer, recurrent non-small cell lung cancer, recurrent esophageal cancer and recurrent malignant pleural mesothelioma, the submission of a clinical trial notification and execution of an implementation agreement are described as new initiatives.