Unresectable AngiosarcomaPhase 2NCT05601232
A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA
A Phase 2 study testing BNCT in people with Unresectable Angiosarcoma, run by Stella Pharma Corporation at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Unresectable Angiosarcoma
- What is being tested?
- BNCT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- 1 Nov 2022to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Unresectable Angiosarcoma
- Being tested
- BNCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNCTRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Boron Neutron Capture Therapy (BNCT) | Experimental | Not described Receives: Radiation: BNCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline until Day90
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline until Day90
Overall survival
From the date of BNCT until death from any causes
Measured: Baseline until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Nov 2022
- Primary completion30 Nov 2024
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable AngiosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stella Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Intelligence Care Systems, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601232
- Sponsor's protocol ID
- CNCT-002/SPM-011-JAM002
- Status last verified
- Apr 2025
- First submitted
- 27 Oct 2022
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Boron Neutron Capture Therapy (BNCT) for Patients With Unresectable Angiosarcoma, by Using CICS-1 and SPM-011
- ClinicalTrials.gov ID
- NCT05601232
- Acronym / sponsor ID
- CNCT-002/SPM-011-JAM002
- Conditions
- Unresectable Angiosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stella Pharma CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Intelligence Care Systems, Inc.
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boron Neutron Capture Therapy (BNCT) | Experimental | Radiation: BNCT |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNCTPatients 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. | Radiation | Boron Neutron Capture Therapy (BNCT) |
Primary outcome
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
11 secondary outcomes
Response rate as assessed by the investigator according to RECISTv1.1
Time frame: Baseline until Day90
Duration of response as assessed by the IRF and the investigator
Time frame: Baseline until disease progression or death
Time to response as assessed by the IRF
Time frame: Baseline until the initial occurrence of CR or PR
Complete response (CR) rate as assessed by the IRF and the investigator
Time frame: Baseline until the initial occurrence of CR
Disease control rate as assessed by the IRF and the investigator
Time frame: Baseline until the initial occurrence of CR, PR or SD
Overall response rate as assessed by the IRF and the investigator
Time frame: Baseline until the initial occurrence of CR or PR
Locoregional progression-free survival as assessed by the investigator
Time frame: Baseline until in-field disease progression
Extra-regional relapse-free survival as assessed by the investigator
Time frame: Baseline until extra-field disease progression
Progression-free survival as assessed by the IRF and the investigator
Time frame: 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
Time frame: Baseline until Day90
Overall survival
Time frame: Baseline until death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BNCT in people with Unresectable Angiosarcoma, run by Stella Pharma Corporation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.