Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273852
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-02-15
Brief Title:
A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors
Sponsor:
Pure Biologics SA
Organization:
Pure Biologics SA
Study Overview
Official Title:
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
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 multi-center single arm open-label localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device
Detailed Description:
CIVO is a research tool composed of a hand-held single-use sterile injector coupled with fluorescent tracking microspheres called CIVO GLO that mark the sites of drug microdose injection enabling rapid assessment of multiple oncology drugs or drug combinations simultaneously within a patients tumor In this Phase 0 intratumoral microdosing study in human patients with localized or metastatic primary HNSCC STS or TNBC tumors who will be undergoing previously planned tumor and regional nodes dissection we will evaluate PBA-0405s ability to trigger a variety of immune-mediated effector functions that kill tumor cells within the local tumor microenvironment
The CIVO device penetrates solid tumors and delivers subtherapeutic microdoses of up to eight anti-cancer agents or combinations of anti-cancer agents co-injected with CIVO GLO into discrete regions of the tumor At the time of the planned surgical intervention one to two days after the CIVO microdose injection the injected tumor tissue is then excised and tumor responses are assessed via histological staining of tumor cross-sections sampled perpendicular to each injection column Co-injection with CIVO GLO enables identification of each injection site during resection as well as in tissues stained for analysis Because the platform delivers microdose amounts of each test agent or combination directly into the patients tumor tissue hypotheses can be tested earlier in the drug development process consistent with the goals of the 2006 FDA Exploratory IND Guidance for Industry
The CIVO device penetrates solid tumors and delivers subtherapeutic microdoses of up to eight anti-cancer agents or combinations of anti-cancer agents co-injected with CIVO GLO into discrete regions of the tumor At the time of the planned surgical intervention one to two days after the CIVO microdose injection the injected tumor tissue is then excised and tumor responses are assessed via histological staining of tumor cross-sections sampled perpendicular to each injection column Co-injection with CIVO GLO enables identification of each injection site during resection as well as in tissues stained for analysis Because the platform delivers microdose amounts of each test agent or combination directly into the patients tumor tissue hypotheses can be tested earlier in the drug development process consistent with the goals of the 2006 FDA Exploratory IND Guidance for Industry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None