Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06603987

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Osaka, 541-0043, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

［18F］FBPA

Diagnostic Test

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

Primary outcomes

  1. Occurrence rate of dose-limiting toxicity

    Time frame: Baseline until Day180

  2. RECIST v1.1

    Time frame: Baseline until Day180

Sponsors and collaborators

Lead sponsor

Stella Pharma Corporation

Industry

Collaborators

  • Cancer Intelligence Care Systems, Inc.
  • Sumitomo Heavy Industries, Ltd.

Registry information

Official study title

Phase I/II Basket Trial: Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Patients With Recurrent Solid Malignant Thoracic Tumors That Are Unresectable and Perceived Challenging to Treat With Standard Treatment

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.