Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615635
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
Clinical Study Protocol for Cutaneous SCC for Immunocompromised Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pivotal Single Arm Open Label Clinical Study to Assess the Safety and Efficacy of Intratumoral Alpha DaRT224 for the Treatment of Immunocompromised Patients With Cutaneous Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DaRT
Brief Summary:
This is a multi-center clinical study enrolling up to 28 participants The primary objectives are to determine the objective response rate ORR established by the confirmed best overall response BOR following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy Secondary objectives are to
1 Determine Progression Free Survival PFS up to 12 months after Alpha DaRT sources insertion
2 Assess Overall Survival OS of patients treated with DaRT up to 12 months
3 Assess Local control up to 12 months after DaRT insertion
1 Determine Progression Free Survival PFS up to 12 months after Alpha DaRT sources insertion
2 Assess Overall Survival OS of patients treated with DaRT up to 12 months
3 Assess Local control up to 12 months after DaRT insertion
Detailed Description:
This study is a pivotal multicenter single arm open label clinical study to assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of of Immunocompromised Patients with Cutaneous Squamous Cell Carcinoma
The Diffusing Alpha-emitter Radiation Therapy DaRT based on the intratumoral placement of an encapsulated Radium-224 source 37 days half-life is described in this study These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil Alpha DaRT sources will be inserted into Cutaneous Squamous Cell Carcinoma tumors and will be removed following 14-21 days
The The objective response rate ORR which is calculated as the percent of patients achieving an objective response Best overall response using the Response Evaluation Criteria in Solid Tumors guidelines RECIST v11 Best overall response is assessed starting from DaRT removal Safety will be assessed based on the cumulative incidence rate severity and outcome of device related Adverse Events AEs Classification of AEs will be done according to CTCAE v5
The Diffusing Alpha-emitter Radiation Therapy DaRT based on the intratumoral placement of an encapsulated Radium-224 source 37 days half-life is described in this study These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil Alpha DaRT sources will be inserted into Cutaneous Squamous Cell Carcinoma tumors and will be removed following 14-21 days
The The objective response rate ORR which is calculated as the percent of patients achieving an objective response Best overall response using the Response Evaluation Criteria in Solid Tumors guidelines RECIST v11 Best overall response is assessed starting from DaRT removal Safety will be assessed based on the cumulative incidence rate severity and outcome of device related Adverse Events AEs Classification of AEs will be done according to CTCAE v5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None