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Phase 1 clinical trial of Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for Malignant melanoma and angiosarcoma

Phase 1 clinical trial of Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for Malignant melanoma and angiosarcoma

Cancer Intelligence Care Systems, Inc

TOC Ariake WestTower 17th Floor, 3-5-7 Ariake, Koto-ku, Tokyo 135-0063 Japan

cics_pv1@cics.jp

Cancer Intelligence Care Systems, Inc

TOC Ariake WestTower 17th Floor, 3-5-7 Ariake, Koto-ku, Tokyo 135-0063 Japan

+81-3-3529-6301

cics_pv1@cics.jp

completed

Nov. 19, 2019

Interventional

Single-center, open label, single armed study

treatment purpose

1

1.Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically
2.Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less
3.Patients with lesions that are 6 cm or less from the skin surface to the deepest part of the tumor
4.Patients with lesions in the head, neck, chest, or extremities
5.Patients who do not have apparent abnormal values in the latest screening test within 28 days of registration

1.Patients with obvious disseminated lesions
2.Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion.
3.Patients with active lesions / active multiple cancers in addition to the target lesion
4.Patients with infections that require systemic treatment.
5.Patients with active implantable medical devices
6. Patients with a history of BNCT treatment

Both

Malignant Melanoma or Angiosarcoma

investigational material(s)
Generic name etc : SPM-011(investigational drug), CICS-1 (investigational device)
INN of investigational material : Borofalan(10B)
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Intravenous administration of SPM-011 and neutron irradiation with CICS-1

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
-Evaluate the safety of each dose level from the frequency of DLT occurrence
-Evaluate the incidence of adverse events and failures during the study period

efficacy
-Tumor shrinkage rate, tumor best shrinkage rate
-Response rate
-Progression-free survival, survival period,best response rate for target lesion,locally progression-free period, period until chronic adverse event

+81-3-3542-2511

Oct. 16, 2019