Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919238
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2023-05-19
Brief Title:
Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma
Sponsor:
Impact Biotech Ltd
Organization:
Impact Biotech Ltd
Study Overview
Official Title:
A Multicenter Open-label Phase 1 Trial to Evaluate Safety and Preliminary Efficacy of Endovascularly Applied Vascular Targeted Photodynamic Therapy VTP for Patients With Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multicenter non-randomized open label light dose escalation phase I trial to evaluate the safety and preliminary efficacy of Padeliporfin vascular targeted photodynamic therapy VTP applied via endovascular fiber placement within a dilatation catheter through the superior mesenteric artery SMA in patients with stage III locally advanced LA unresectable pancreatic ductal adenocarcinoma PDAC The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation
Detailed Description:
This is a prospective multicenter non-randomized open label light dose escalation phase I trial to evaluate the safety and preliminary efficacy of Padeliporfin vascular targeted photodynamic therapy VTP applied via endovascular fiber placement within a dilatation catheter through the superior mesenteric artery SMA in patients with stage III locally advanced LA unresectable pancreatic ductal adenocarcinoma PDAC with SMA solid tumor encasement 180 The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation
Study Intervention Patients enrolled in the study will undergo endovascular VTP using Padeliporfin WST-11 activated via endovascular fiber placement through the SMA with intravenous administration of Padeliporfin at a fixed dose of 4 mgkg of padeliporfin di-potassium followed by total of 10 min illumination at 753 nm
For light dose escalation Part A a 33 dose-escalation schema will be used In a subsequent expansion phase Part B the optimal light dose as per light dose escalation will be used in an additional cohort of patients to further evaluate preliminary efficacy
Study Intervention Patients enrolled in the study will undergo endovascular VTP using Padeliporfin WST-11 activated via endovascular fiber placement through the SMA with intravenous administration of Padeliporfin at a fixed dose of 4 mgkg of padeliporfin di-potassium followed by total of 10 min illumination at 753 nm
For light dose escalation Part A a 33 dose-escalation schema will be used In a subsequent expansion phase Part B the optimal light dose as per light dose escalation will be used in an additional cohort of patients to further evaluate preliminary efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None