A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA

Sponsor

Stella Pharma Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05601232

Collaborator

Cancer Intelligence Care Systems, Inc. (Industry)

Enrollment

Location

Arm

29.9

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate efficacy and safety Boron Neutron Capture Therapy (BNCT) by using CICS-1 accelerator-based neutron capture therapy device with lithium targets developed by CICS, and the SPM-011 boron compound for use in BNCT developed by STELLA PHARMA in the treatment of unresectable angiosarcoma.

Condition or Disease	Intervention/Treatment	Phase
Unresectable Angiosarcoma	Radiation: BNCT	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Boron Neutron Capture Therapy (BNCT) for Patients With Unresectable Angiosarcoma, by Using CICS-1 and SPM-011

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Boron Neutron Capture Therapy (BNCT)	Radiation: BNCT 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.

Arm

Intervention/Treatment

Experimental: Boron Neutron Capture Therapy (BNCT)

Radiation: BNCT

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.

Outcome Measures

Primary Outcome Measures

Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Baseline until Day90]
Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT

Secondary Outcome Measures

Response rate as assessed by the investigator according to RECISTv1.1 [Baseline until Day90]
Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT
Duration of response as assessed by the IRF and the investigator [Baseline until disease progression or death]
From the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first, until confirmed disease progression or death, whichever occurred first
Time to response as assessed by the IRF [Baseline until the initial occurrence of CR or PR]
From the date of BNCT until the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first
Complete response (CR) rate as assessed by the IRF and the investigator [Baseline until the initial occurrence of CR]
Percentage of patients with CR for target lesions after BNCT
Disease control rate as assessed by the IRF and the investigator [Baseline until the initial occurrence of CR, PR or SD]
Percentage of patients with CR, PR and SD for target lesions after BNCT
Overall response rate as assessed by the IRF and the investigator [Baseline until the initial occurrence of CR or PR]
Percentage of patients with CR or PR after BNCT
Locoregional progression-free survival as assessed by the investigator [Baseline until in-field disease progression]
From the date of BNCT until confirmed in-field disease progression
Extra-regional relapse-free survival as assessed by the investigator [Baseline until extra-field disease progression]
From the date of BNCT until confirmed extra-field disease progression (new lesions)
Progression-free survival as assessed by the IRF and the investigator [Baseline until disease progression or death]
From the date of BNCT until confirmed disease progression or death, whichever occurred first
Maximum percent change in sum of tumor diameters of target lesions as assessed by the IRF and the investigator [Baseline until Day90]
Maximum percent change in sum of tumor diameters of target lesions within 90 days after BNCT
Overall survival [Baseline until death]
From the date of BNCT until death from any causes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Written informed consent must be obtained from the subject.
Histologically documented primary skin angiosarcoma.
Locally advanced or locally recurrent angiosarcoma, and not eligible for curative surgery, chemoradiotherapy or radiotherapy.
Measurable disease, as defined by RECIST v1.1.

Exclusion Criteria:

Apparent disseminated tumor lesions.
Hereditary fructose intolerance.
Phenylketonuria.
Any serious concomitant disease that precludes completion of the study treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center Hospital	Tokyo		Japan

Sponsors and Collaborators

Stella Pharma Corporation
Cancer Intelligence Care Systems, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stella Pharma Corporation

ClinicalTrials.gov Identifier:

NCT05601232

Other Study ID Numbers:

CNCT-002/SPM-011-JAM002

First Posted:

Nov 1, 2022

Last Update Posted:

Nov 28, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemangiosarcoma

Study Results

No Results Posted as of Nov 28, 2022