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A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT06533644•Syncromune, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Male \>=18 years old.
•Able to provide written informed consent and comply with the study procedures.
•Participants with advanced and/or metastatic histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.
•Serum testosterone levels less than or equal to (\<=) 0.5 nanograms per millilitre (ng/mL) (\<=1.73 nanomoles per litre \[nmol/L\]) at screening if on anti-hormonal therapy.
•Progression after the receipt of one or more approved second-generation androgen-receptor-pathway inhibitors with or without a prior course of taxane therapy, and those who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available, and has not received more than three prior lines of therapy. If a poly adenosine diphosphate ribose (ADP)-ribose polymerase (PARP)-positive participants chose not to receive an approved PARP-inhibitor they will be eligible for the study.
•Able to undergo general anesthesia or conscious sedation.
•Has undergone a cardiac work-up and received cardiac clearance within 2 months before first treatment.
•Eastern Cooperative Oncology Group (ECOG) performance status of less than (\<) 3.
•Life expectancy \>=6 months
•Last dose of previous anticancer therapy (excluding hormonal therapy) must by 28 days or more prior to first study treatment.
+9 more criteria

Exclusion Criteria

•Has a known other primary malignancy other than prostate cancer that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma, papillary thyroid cancer, and ductal carcinoma in situ of the breast.
•Has an obstructed urinary system before or after stenting.
•Has undergone major surgery, including local prostate intervention (excluding prostate biopsy), within 28 days prior to the first dose of study treatment and has not recovered adequately from the toxicities and/or complications.
•Has used any anticoagulants or other blood thinners pre-study treatments within the protocol-defined timelines.
•Has an active infection (including tuberculosis) requiring systemic therapy.
•Has a history of non-infectious pneumonitis that requires steroids.
•Has received a live vaccine within 30 days prior to the enrollment.
•Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to the first study treatment.
•Significant cardiac or other medical illness such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia (e.g., New York Heart Association Class 4), or history of previous heart failure.
•Fridericia corrected QT interval (QTcF) greater than (\>) 470 millisecond (msec) (men) on a 12-lead electrocardiogram (ECG) during the screening period.
+12 more criteria

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

Key Dates

Start Date

May 29, 2025

Primary Completion Date

December 14, 2027

Completion Date

December 14, 2027

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

Partial Oncolysis

PROCEDURE

SV-102

DRUG

Contacts

Central Contact

CONTACT

888-636-5344 info@legion100trial.com

www.legion100trial.com

CONTACT

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Metastatic Castration-Resistant Prostate Cancer

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Endometrial CancerGastric Cancer+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer