NCT05544227

Phase 1 Trial of SYNC-T - Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer

Immunotherapy Regimen Given After Targeted Local Cryolysis (TLC) for Patients With Advanced/Metastatic Castration-resistant Prostate Cancer (mCRPC) OR Those With Metastatic Prostate Cancer Who Refused Hormone Therapy and Chemotherapy.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Williams Cancer Foundation · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (TSA/TAAs) 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.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	SV-102	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 immunopharmacologic effects.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-12-10
• Completion: 2025-06-01
• First posted: 2022-09-16
• Last updated: 2025-07-23

Locations

1 site across 1 country: Mexico