NCT06533644 · Syncromune, Inc.
A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer
What this study is about
The primary purpose of this study is to evaluate the safety, tolerability, and effectiveness of SYNC-T Therapy SV-102 and to identify the maximum tolerated dose (MTD) and/or selected dose for phase 2b study.
View original scientific description
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.
Interventions
PROCEDURE
Partial Oncolysis
Partial tumor oncolysis will be completed by cryolysis.
DRUG
SV-102
Intratumoral infusion of SV-102
Primary outcome measures
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Immune-related Adverse Reactions (imARs)
Time frame: Up to 2 years
Maximum Tolerated Dose
Time frame: Up to 48 weeks
The MTD will be defined as the highest dose level below the dose level at which 2 or more participant experience a dose limiting toxicity (DLT).
Optimal Biologic Dose (OBD)
Time frame: Up to 48 weeks
OBD will be determined based on DLT and dose escalation part data.
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 48 weeks
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the expansion phase, based on data collected during the dose escalation portion of the study.
Objective Response Rate (ORR)
Time frame: Up to 2 years
The ORR is defined as the percentage of participants who achieved best overall response (BOR) of complete response (CR) or partial response (PR).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Sacramento, California
- Jacksonville, Florida
- Miami, Florida
- Tampa, Florida
- Chicago, Illinois
- Lisle, Illinois
- Wichita, Kansas
- Shreveport, Louisiana
- Troy, Michigan
And 10 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations