NCT06603987View on ClinicalTrials.gov

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

PHASE1/PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 10, 2025

Primary Completion Date

October 31, 2028

Study Completion Date

October 31, 2028

Conditions
Thoracic Solid Malignant Tumor
Interventions
RADIATION

BNCT

Patients will be infused SPM-011 intravenously at a dose of 200mg/kg/hr over 2 hours. Thereafter, patient will be infused SPM-011 intravenously at a dose of 100mg/kg/hr and will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood.

DIAGNOSTIC_TEST

［18F］FBPA

Intravenous injection of ［18F］FBPA and radiation exposure from PET-CT scan.

Trial Locations (1)

541-0043

ORIX Kouraibashi Bldg. 8F 3-2-7 Kouraibashi Chuo-ku, Osaka

All Listed Sponsors
collaborator

Cancer Intelligence Care Systems, Inc.

INDUSTRY

collaborator

Sumitomo Heavy Industries, Ltd.

UNKNOWN

lead

Stella Pharma Corporation

INDUSTRY

NCT06603987 - Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA | Biotech Hunter | Biotech Hunter