Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA

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

Status

Enrolling by invitation

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06603987

Enrollment

Registered

2024-09-19

Start date

2025-04-10

Completion date

2028-10-31

Last updated

2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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. 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.

Interventions

RADIATIONBNCT

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.

DIAGNOSTIC_TEST［18F］FBPA

Intravenous injection of ［18F］FBPA and radiation exposure from PET-CT scan.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Occurrence rate of dose-limiting toxicity	Baseline until Day180
RECIST v1.1	Baseline until Day180

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026