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NCT Number: NCT05601232

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Unresectable Angiosarcoma

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center Hospital

Tokyo, 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.
  • 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.

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.

Primary outcomes

  1. Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Baseline until Day90

    Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT

Secondary outcomes

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

    Time frame: Baseline until Day90

    Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT

  2. Duration of response as assessed by the IRF and the investigator

    Time frame: Baseline until disease progression or death

    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

  3. Time to response as assessed by the IRF

    Time frame: Baseline until the initial occurrence of CR or PR

    From the date of BNCT until the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first

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

    Time frame: Baseline until the initial occurrence of CR

    Percentage of patients with CR for target lesions after BNCT

  5. Disease control rate as assessed by the IRF and the investigator

    Time frame: Baseline until the initial occurrence of CR, PR or SD

    Percentage of patients with CR, PR and SD for target lesions after BNCT

  6. Overall response rate as assessed by the IRF and the investigator

    Time frame: Baseline until the initial occurrence of CR or PR

    Percentage of patients with CR or PR after BNCT

  7. Locoregional progression-free survival as assessed by the investigator

    Time frame: Baseline until in-field disease progression

    From the date of BNCT until confirmed in-field disease progression

  8. Extra-regional relapse-free survival as assessed by the investigator

    Time frame: Baseline until extra-field disease progression

    From the date of BNCT until confirmed extra-field disease progression (new lesions)

  9. Progression-free survival as assessed by the IRF and the investigator

    Time frame: Baseline until disease progression or death

    From the date of BNCT until confirmed disease progression or death, whichever occurred first

  10. Maximum percent change in sum of tumor diameters of target lesions as assessed by the IRF and the investigator

    Time frame: Baseline until Day90

    Maximum percent change in sum of tumor diameters of target lesions within 90 days after BNCT

  11. Overall survival

    Time frame: Baseline until death

    From the date of BNCT until death from any causes

Sponsors and collaborators

Lead sponsor

Stella Pharma Corporation

Industry

Collaborators

  • Cancer Intelligence Care Systems, Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Nov 1, 2022
Registry last updated
Apr 9, 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.