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

Launched by STELLA PHARMA CORPORATION · Sep 16, 2024

Keywords

ClinConnect Summary

This trial is testing Boron Neutron Capture Therapy (BNCT) for people with recurrent thoracic solid tumors (cancers in the chest area) that cannot be removed with surgery and are hard to treat with standard radiation or drugs. It’s a basket study, meaning it includes several related cancers in the chest (like certain lung, esophageal, mesothelioma, breast, and soft tissue sarcomas). The study uses a boron-containing drug given through a vein, followed by neutron irradiation to target the tumor, with a special PET scan ([18F]FBPA) to help decide if BNCT is appropriate for the patient. The trial aims primarily to assess safety (whether dose-limiting toxicity occurs) and how well tumors respond, measured from before treatment up to about 6 months (Day 180).

Who may be eligible: adults aged 18 to 85 with measurable, unresectable thoracic tumors and good overall health (ECOG 0-1). The total size of the tumors to be treated should be 15 cm or less in sum. Exclusions include active other cancers, certain imaging findings, prior radiation to the target area above 65 Gy, serious other health problems, or unresolved complications from previous radiation. The study is currently enrolling by invitation in Osaka, Japan, with an estimated 30 participants. If you join, you’ll receive BNCT infusions over about 2 hours, followed by a second infusion and neutron treatment, plus a PET scan to guide care. Primary results focus on safety and tumor response within the first 6 months, with the study expected to finish around 2028.

Gender

ALL

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.