Clinical Trial · NCT06603987

Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA

Overview

To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy and are unresectable. With "lung," "heart," "liver," "spinal cord," and "esophagus" as common risk organs in the treatment plan for BNCT using therapeutic CT to evaluate the safety and efficacy of BNCT in patients with unresectable and recurrent thoracic solid tumors which are difficult to treat with standard radiation and drug therapy. To evaluate the safety of ［18F］FBPA synthesized with MPS200FBPA. In addition, the usefulness of ［18F］FBPA-PET testing to determine the appropriateness of performing BNCT will be evaluated in an exploratory manner.

Sponsor

Stella Pharma Corporation

Phase

Phase 1/2

ClinicalTrials.gov

NCT06603987

Drug / Compound

FBPA

Isotope(s):

Target(s):

LAT1/LAT2

Ligand Class: Small Molecules

Eligibility

Inclusion

Patients diagnosed with recurrent malignant tumors that are unresectable and perceived challenging to treat with standard treatment.
Patients with histopathological diagnosed malignant tumor (except cutaneous angiosarcoma)
Patients with ECOG performance status score of 0 or 1.
* Written informed consent must be obtained from the subject.
Measurable disease, as defined by RECIST v1.1.

Exclusion

* Patients with active disease or active double cancers other than target lesions.
Patients who received radiation therapy exceeding 65 Gy as a prior treatment for the target lesion.
Any serious concomitant disease that precludes completion of the study treatment.
Patients with imaging findings that affect imaging evaluation of the tumor, such as ground-glass opacities
Patients with remaining complications of Grade 3 or higher related to prior radiation therapy in the irradiation field.