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

A Phase II Study of Boron Neutron Capture Therapy (BNCT) for Patients With Unresectable Angiosarcoma, by Using CICS-1 and SPM-011

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Unresectable Angiosarcoma
• Intervention / Treatment: Radiation: BNCT

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • National Cancer Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT	Baseline until Day90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate as assessed by the investigator according to RECISTv1.1	Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT	Baseline until Day90
Duration of response as assessed by the IRF and the investigator	From the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first, until confirmed disease progression or death, whichever occurred first	Baseline until disease progression or death
Time to response as assessed by the IRF	From the date of BNCT until the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first	Baseline until the initial occurrence of CR or PR
Complete response (CR) rate as assessed by the IRF and the investigator	Percentage of patients with CR for target lesions after BNCT	Baseline until the initial occurrence of CR
Disease control rate as assessed by the IRF and the investigator	Percentage of patients with CR, PR and SD for target lesions after BNCT	Baseline until the initial occurrence of CR, PR or SD
Overall response rate as assessed by the IRF and the investigator	Percentage of patients with CR or PR after BNCT	Baseline until the initial occurrence of CR or PR
Locoregional progression-free survival as assessed by the investigator	From the date of BNCT until confirmed in-field disease progression	Baseline until in-field disease progression
Extra-regional relapse-free survival as assessed by the investigator	From the date of BNCT until confirmed extra-field disease progression (new lesions)	Baseline until extra-field disease progression
Progression-free survival as assessed by the IRF and the investigator	From the date of BNCT until confirmed disease progression or death, whichever occurred first	Baseline until disease progression or death
Maximum percent change in sum of tumor diameters of target lesions as assessed by the IRF and the investigator	Maximum percent change in sum of tumor diameters of target lesions within 90 days after BNCT	Baseline until Day90
Overall survival	From the date of BNCT until death from any causes	Baseline until death

Collaborators and Investigators

• Sponsor: Stella Pharma Corporation
• Collaborators: Cancer Intelligence Care Systems, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): November 30, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Vascular Tissue; Hemangiosarcoma
• Other Study ID Numbers: CNCT-002/SPM-011-JAM002

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