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

November 16, 2025 updated by: Stella Pharma Corporation

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Osaka, Osaka, Japan, 541-0043
        • ORIX Kouraibashi Bldg. 8F 3-2-7 Kouraibashi Chuo-ku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Boron Neutron Capture Therapy (BNCT)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence rate of dose-limiting toxicity
Time Frame: Baseline until Day180
Baseline until Day180
RECIST v1.1
Time Frame: Baseline until Day180
Baseline until Day180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stella Pharma Corporation

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2025

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-BT001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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