A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA

NCT ID: NCT05601232

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-08-31

Brief Summary

The purpose of the study is to investigate efficacy and safety Boron Neutron Capture Therapy (BNCT) by using CICS-1 accelerator-based neutron capture therapy device with lithium targets developed by CICS, and the SPM-011 boron compound for use in BNCT developed by STELLA PHARMA in the treatment of unresectable angiosarcoma.

Conditions

Unresectable Angiosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Boron Neutron Capture Therapy (BNCT)

Group Type: EXPERIMENTAL

BNCT

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Written informed consent must be obtained from the subject.
• Histologically documented primary skin angiosarcoma.
• Locally advanced or locally recurrent angiosarcoma, and not eligible for curative surgery, chemoradiotherapy or radiotherapy. (Including cases where the individual refuses treatment.)
• Measurable disease, as defined by RECIST v1.1.
• The longest diameter of the entire target lesion is 15 cm or less.
• ECOG performance status score of Grade 0 to 2

Exclusion Criteria

• Apparent disseminated tumor lesions.
• Hereditary fructose intolerance.
• Phenylketonuria.
• Any serious concomitant disease that precludes completion of the study treatment.
• The target lesion has received radiation exceeding 75 Gy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Intelligence Care Systems, Inc.

INDUSTRY

Sponsor Role: collaborator

Stella Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cancer Center Hospital

Tokyo, , Japan

Countries

Japan

Other Identifiers

CNCT-002/SPM-011-JAM002

Identifier Type: -

Identifier Source: org_study_id