RecruitingPhase 2NCT06533644

A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer

A Phase 2a Multicenter, Dose-Escalation and Dose Optimization Study of SYNC-T Therapy SV-102 for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)


Sponsor

Syncromune, Inc.

Enrollment

70 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of SYNC-T Therapy SV-102 and to identify the maximum tolerated dose (MTD) and/or selected dose for phase 2b study.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment called SV-102 — part of a platform called SYNC-T therapy — in men with metastatic castration-resistant prostate cancer (mCRPC), meaning prostate cancer that has spread and is no longer responding to hormone-lowering treatments. SYNC-T is a novel approach that combines tumor removal with immune activation to create a personalized in-body immune response against the cancer. This early study focuses on safety, tolerability, and early signs of effectiveness. **You may be eligible if...** - You are a man aged 18 or older with confirmed advanced prostate cancer (adenocarcinoma) - Your testosterone is at very low (castrate) levels from hormone therapy - Your cancer progressed after one or more approved hormone-blocking drugs (like enzalutamide or abiraterone), with or without prior taxane chemotherapy - You have not received more than 3 prior lines of therapy - You are in good enough health to undergo sedation or general anesthesia - Your heart has been cleared by a cardiac assessment within the past 2 months - Your ECOG score is less than 3 **You may NOT be eligible if...** - You have significant organ damage or unresolved side effects from prior treatments - Your last cancer treatment (excluding hormones) was less than 28 days ago - You are unwilling to use contraception during and after treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREPartial Oncolysis

Partial tumor oncolysis will be completed by cryolysis.

DRUGSV-102

Intratumoral infusion of SV-102


Locations(9)

University of Arizona Cancer Center

Tucson, Arizona, United States

Duly Health

Lisle, Illinois, United States

Wichita Urology

Wichita, Kansas, United States

Michigan Institute of Urology

Troy, Michigan, United States

Mercy Hospital

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Northwell Health

Lake Success, New York, United States

Weill Cornell

New York, New York, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06533644


Related Trials