Thoracic Solid Malignant TumorPhase 1/2NCT06603987
Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA
A Phase 1/2 study testing BNCT and ［18F］FBPA in people with Thoracic Solid Malignant Tumor, run by Stella Pharma Corporation at 1 site in Japan.
Trial summary
To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy and are unresectable. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Thoracic Solid Malignant Tumor
- What is being tested?
- BNCT and ［18F］FBPA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 10 Apr 2025to 31 Oct 2028
- Phase
- Phase 1/2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained from the subject.
- Patients with histopathological diagnosed malignant tumor (except cutaneous angiosarcoma)
- Measurable disease, as defined by RECIST v1.1.
- Patients diagnosed with recurrent malignant tumors that are unresectable and perceived challenging to treat with standard treatment.
- Patients with ECOG performance status score of 0 or 1.
Who cannot join
- Patients with active disease or active double cancers other than target lesions.
- Patients with imaging findings that affect imaging evaluation of the tumor, such as ground-glass opacities
- Patients who received radiation therapy exceeding 65 Gy as a prior treatment for the target lesion.
- Any serious concomitant disease that precludes completion of the study treatment.
- Patients with remaining complications of Grade 3 or higher related to prior radiation therapy in the irradiation field.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site
ORIX Kouraibashi Bldg. 8F 3-2-7 Kouraibashi Chuo-ku
Osaka, Osaka, 541-0043
About this study
Official title: Phase I/II Basket Trial: Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Patients With Recurrent Solid Malignant Thoracic Tumors That Are Unresectable and Perceived Challenging to Treat With Standard Treatment
To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy and are unresectable. With "lung," "heart," "liver," "spinal cord," and "esophagus" as common risk organs in the treatment plan for BNCT using therapeutic CT to evaluate the safety and efficacy of BNCT in patients with unresectable and recurrent thoracic solid tumors which are difficult to treat with standard radiation and drug therapy.
To evaluate the safety of ［18F］FBPA synthesized with MPS200FBPA. In addition, the usefulness of ［18F］FBPA-PET testing to determine the appropriateness of performing BNCT will be evaluated in an exploratory manner.
- Conditions
- Thoracic Solid Malignant Tumor
- Being tested
- BNCT, ［18F］FBPA
- Keywords
- Esophageal Cancer, Non Small Cell Lung Cancer, Breast Cancer, Malignant Soft Tissue Sarcoma, Malignant Pleural Mesothelioma, Malignant Peripheral Nerve Sheath Tumors
- Medical subject headings
- Esophageal Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Mesothelioma, Malignant, Neurofibrosarcoma
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.
［18F］FBPADiagnostic test
Intravenous injection of ［18F］FBPA and radiation exposure from PET-CT scan.
| Study group | Role | What they receive |
|---|---|---|
| Boron Neutron Capture Therapy (BNCT) | Experimental | Not described Receives: Radiation: BNCT; Diagnostic Test: ［18F］FBPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence rate of dose-limiting toxicity
Measured: Baseline until Day180
RECIST v1.1
Measured: Baseline until Day180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Apr 2025
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Solid Malignant TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stella Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Intelligence Care Systems, Inc., Sumitomo Heavy Industries, Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603987
- Sponsor's protocol ID
- SJ-BT001
- Status last verified
- Nov 2025
- First submitted
- 12 Sep 2024
- Last updated
- 19 Nov 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Basket Trial: Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Patients With Recurrent Solid Malignant Thoracic Tumors That Are Unresectable and Perceived Challenging to Treat With Standard Treatment
- ClinicalTrials.gov ID
- NCT06603987
- Acronym / sponsor ID
- SJ-BT001
- Conditions
- Thoracic Solid Malignant Tumor
- Keywords
- Esophageal Cancer, Non Small Cell Lung Cancer, Breast Cancer, Malignant Soft Tissue Sarcoma, Malignant Pleural Mesothelioma, Malignant Peripheral Nerve Sheath Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stella Pharma CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Intelligence Care Systems, Inc., Sumitomo Heavy Industries, Ltd.
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy and are unresectable. With "lung," "heart," "liver," "spinal cord," and "esophagus" as common risk organs in the treatment plan for BNCT using therapeutic CT to evaluate the safety and efficacy of BNCT in patients with unresectable and recurrent thoracic solid tumors which are difficult to treat with standard radiation and drug therapy.
To evaluate the safety of ［18F］FBPA synthesized with MPS200FBPA. In addition, the usefulness of ［18F］FBPA-PET testing to determine the appropriateness of performing BNCT will be evaluated in an exploratory manner.
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, Diagnostic Test: ［18F］FBPA |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent must be obtained from the subject.
- Patients with histopathological diagnosed malignant tumor (except cutaneous angiosarcoma)
- Measurable disease, as defined by RECIST v1.1.
- Patients diagnosed with recurrent malignant tumors that are unresectable and perceived challenging to treat with standard treatment.
- Patients with ECOG performance status score of 0 or 1.
Key exclusion criteria (5 listed)
- Patients with active disease or active double cancers other than target lesions.
- Patients with imaging findings that affect imaging evaluation of the tumor, such as ground-glass opacities
- Patients who received radiation therapy exceeding 65 Gy as a prior treatment for the target lesion.
- Any serious concomitant disease that precludes completion of the study treatment.
- Patients with remaining complications of Grade 3 or higher related to prior radiation therapy in the irradiation field.
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) |
| ［18F］FBPAIntravenous injection of ［18F］FBPA and radiation exposure from PET-CT scan. | Diagnostic test | Boron Neutron Capture Therapy (BNCT) |
Primary outcome
Occurrence rate of dose-limiting toxicity
Time frame: Baseline until Day180
RECIST v1.1
Time frame: Baseline until Day180
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 19 Nov 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.
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 1/2 study testing BNCT and ［18F］FBPA in people with Thoracic Solid Malignant Tumor, 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 5 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: enrolling by invitation, as of the sponsor's last update on 19 Nov 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Occurrence rate of dose-limiting toxicity (time frame: Baseline until Day180). The study lists 2 primary outcomes in all. 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 19 Nov 2025.