Clinical trial NCT06603987: Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
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
Lead sponsor: Stella Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: Cancer Intelligence Care Systems, Inc.
name: Sumitomo Heavy Industries, Ltd.
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.
* Patients whose longest diameter sum of the lesions to be treated is 15 cm or less.

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.

Primary outcomes:
measure: Occurrence rate of dose-limiting toxicity
timeFrame: Baseline until Day180
measure: RECIST v1.1
timeFrame: Baseline until Day180
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: ORIX Kouraibashi Bldg. 8F 3-2-7 Kouraibashi Chuo-ku
Study officials:
References: