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

NCT06603987 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: SJ-BT001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Solid Malignant Tumor

Keywords

Esophageal Cancer; Non Small Cell Lung Cancer; Breast Cancer; Malignant Soft Tissue Sarcoma; Malignant Pleural Mesothelioma; Malignant Peripheral Nerve Sheath Tumors

Outcome Measures

Primary Outcomes (2)

• Occurrence rate of dose-limiting toxicity

  Baseline until Day180

• RECIST v1.1

  Baseline until Day180

Study Arms (1)

Boron Neutron Capture Therapy (BNCT)

EXPERIMENTAL

Radiation: BNCT; Diagnostic Test: ［18F］FBPA

Interventions

BNCT RADIATION

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.

Boron Neutron Capture Therapy (BNCT)

［18F］FBPA DIAGNOSTIC_TEST

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

Boron Neutron Capture Therapy (BNCT)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with active disease or active double cancers other than target lesions.
• Patients with imaging findings that affect imaging evaluation of the tumor, such as ground-glass opacities
• 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 remaining complications of Grade 3 or higher related to prior radiation therapy in the irradiation field.

Sponsors & Collaborators

• Stella Pharma Corporation: lead
• Cancer Intelligence Care Systems, Inc.: collaborator
• Sumitomo Heavy Industries, Ltd.: collaborator

Study Sites (1)

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

Osaka, Osaka, 541-0043, Japan

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Mesothelioma, Malignant; Neurofibrosarcoma

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Pleural Neoplasms; Fibrosarcoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)