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

NCT05601232 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CNCT-002/SPM-011-JAM002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Response rate as assessed by the investigator according to RECISTv1.1

  Baseline until Day90

• Duration of response as assessed by the IRF and the investigator

  Baseline until disease progression or death

• Time to response as assessed by the IRF

  Baseline until the initial occurrence of CR or PR

• Complete response (CR) rate as assessed by the IRF and the investigator

  Baseline until the initial occurrence of CR

• Disease control rate as assessed by the IRF and the investigator

  Baseline until the initial occurrence of CR, PR or SD

Study Arms (1)

Boron Neutron Capture Therapy (BNCT)

EXPERIMENTAL

Radiation: BNCT

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)

Eligibility Criteria

• Age: 18 Years - 89 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stella Pharma Corporation: lead
• Cancer Intelligence Care Systems, Inc.: collaborator

Study Sites (1)

National Cancer Center Hospital

Tokyo, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 1, 2022
• Study Start: November 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: August 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)