Ignite Creation Date:
2024-05-06 @ 6:06 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05544227
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2022-08-16
Brief Title:
Phase 1 Trial of SYNC-T - Immunotherapy for AdvancedMetastatic Castration-Resistant Prostate Cancer
Sponsor:
Williams Cancer Foundation
Organization:
Williams Cancer Foundation
Study Overview
Official Title:
Immunotherapy Regimen Given After Targeted Local Cryolysis TLC for Patients With AdvancedMetastatic Castration-resistant Prostate Cancer mCRPC OR Those With Metastatic Prostate Cancer Who Refused Hormone Therapy and Chemotherapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
SV-102 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects
Detailed Description:
SV-102 is intended for immunotherapeutic treatment of solid tumors in certain metastatic cancer indications SYNC-T technology encompasses methods and compositions that mediate multiple pharmacologic effects aimed at mounting a synchronized and multi-faceted antitumor immune response The first component of SYNC-T is aimed at eliciting in situ immunization by triggering the lysis and immunogenic cell death of tumor cells followed by the release of tumor-specific or tumor-associated antigens TSATAAs and danger associated molecular patterns DAMPs into the tumor microenvironment The main approach that will be used by SYNC-T will rely on partial and targeted local cryolysis of tumor cells mediated by a cryolysis device The second component of SYNC-T technology is the intratumoral infusion of a low-dose multi-component drug product
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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