A Study of SYNC-T Therapy SV-102 for Metastatic Castration-Resistant Prostate Cancer
This study is testing a treatment called SYNC-T Therapy SV-102 for men with metastatic castration-resistant prostate cancer (prostate cancer that has spread and no longer responds to hormone therapy). The treatment involves a procedure called partial oncolysis (cryolysis, which uses freezing to destroy part of the tumor) followed by injecting SV-102 directly into the tumor. Researchers want to find out how safe SV-102 is, what side effects it might cause, and the best dose to use. They also want to see how well it works. This study is currently recruiting about 91 participants who are at least 18 years old and have advanced prostate cancer.
- Study design
- This interventional study aims to enroll about 91 participants. It is designed to evaluate the safety, tolerability, and effectiveness of SYNC-T Therapy SV-102.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events for up to 2 years after treatment.
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NCT06533644
A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentSyncromune, Inc.
~91 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Partial OncolysisSV-102
At a glance
Recruiting sites
14 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Immune-related Adverse Reactions (imARs)
Measured over Up to 2 years
+4 more outcomes measured
Conditions
Where it's being run
23 sites across 16 statesFlorida3
New York3
Arizona2
Illinois2
Pennsylvania2
Arkansas1
California1
Kansas1
Study leadership
- Stephen Dale, MD · STUDY_DIRECTOR · Syncromune, Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 or neuroendocrine transformation.
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 an androgen receptor prostate inhibitor in combination with Androgen Deprivation Therapy (ADT).
Progression (as defined below) after the receipt of at least one or more approved second-generation androgen-receptor-pathway inhibitors with or without a prior course of taxane therapy, as long as the subject has not received more than three lines of therapy in the CRPC setting. If a subject is known positive for any of the specific gene mutations of BRCA1/2, PALB2, or HRD and chose not to receive an approved PARP-inhibitor they are eligible for the study. Documented progressive disease at screening as assessed by the Investigator with at least one of the following criteria:
Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart. 1.0 ng/mL is the minimal starting value if confirmed rise is only indication of progression.
Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3).
Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression.
Able to undergo general anesthesia, MAC anesthesia, or conscious sedation.
Eastern Cooperative Oncology Group (ECOG) performance status of less than (\<) 2.
Life expectancy \>=6 months
Last dose of previous anticancer therapy (excluding hormonal therapy) must by 28 days prior to first study treatment. For subjects who previously received lutetium Lu 177 vipivotide tetraxetan (Pluvicto®), the last dose must have been administered \> 90 days prior to first study treatment. Subjects may remain on ADT and/or androgen receptor pathway inhibitor at time of study entry, per Investigator discretion.
Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy.
For males with female partners of childbearing potential, even if surgically sterilized (that is \[i.e.\], status post vasectomy), who agree to practice:
Must have at least one measurable lesion per RECIST v1.1 at time of screening.
Must have at least one lesion suitable for SYNC-T Therapy identified by radiographic imaging as defined below:
Soft tissue lesion (e.g., prostate, lung) must be at least 1 cm in at least two dimensions.
Lymph node lesion of at least 1.5 cm (short axis) or 1.0 cm if positive per PET scan.
Exophytic component of a bone lesion that is measurable per RECIST v1.1. Soft tissue and lymph nodes must be demonstrable on CT/MRI and accessible either transperineally or percutaneously to permit tumor biopsy, cryolysis, and immunotherapy infusion.
Participants receiving bone resorptive therapy must be on stable doses for at least 42 days prior to the oncolysis.
In the opinion of the Investigator, there is no other meaningful life prolonging therapy option available, or the participant refuses other therapy, outside of anti-hormonal therapy.
Adequate bone marrow, renal, and hepatic function.
Participants agrees to provide tumor tissue and undergo an on-treatment tumor biopsy.
Exclusion
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 planned first study treatment.
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.
Malignant pleural effusions or ascites that require immediate intervention.
Brain metastases (includes history of).
Immunocompromised status due to:
Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.
Other immunodeficiency diseases that in the opinion of the Investigator, with consultation with Medical Monitor, could compromise the participant or limit treatment efficacy.
Uncontrolled or unmanaged diabetes, hypersensitivity, or other illness or disease that in the opinion of the Investigator, with consultation with Medical Monitor (MM), makes the subject a poor candidate.
History of bone marrow/stem cell transplant.
Participants having human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) are not eligible for enrollment.
Active coronavirus disease-2019 (COVID-19) infection or tests positive for COVID-19 a day before or the day of planned study treatment.
Participants who have active viral (any etiology) hepatitis are excluded.
Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen \[HBsAg\] test and a positive hepatitis B core antibody (anti-HBc) test) who have a viral load below the limit quantification (HBV deoxyribonucleic acid \[DNA\] titer \<1000 copies per milliliters \[cps/mL\] or 200 international units per milliliter \[IU/mL\]) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor.
Participants with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and have a viral load below the limit of quantification are eligible for study entry. Known or suspected hepatitis C infection which has not been treated and cured are not eligible. Known or suspected hepatitis C currently on treatment with an undetectable viral load are eligible. Patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and have a viral load below the limit of quantification are eligible for study entry.
Participants with complications or contraindications related to the liver, including intrahepatic biliary ductal dilation, uncorrectable bleeding diathesis, and decompensated liver failure.
Breast cancer gene (BRCA) mutation testing will be required for participants not previously treated with a PARP inhibitor, unless BRCA status is established prior to screening. If PARP-positive and participants agree to PARP therapy, they will be ineligible.
Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study treatment, or interfere with participants compliance or conduct of this study.
Known visceral metastases, except for lung metastases.
Known substance abuse or medical, psychological, or social conditions that may interfere with patient's participation.
Participants who have received both chemotherapy and lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in the CRPC setting.
What this trial 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)Up to 2 years
- Maximum Tolerated DoseUp 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)Up to 48 weeks
OBD will be determined based on DLT and dose escalation part data.
- Recommended Phase 2 Dose (RP2D)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)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).