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Metastatic Castration-resistant Prostate CancerPhase 2NCT06533644

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

A Phase 2 study testing Partial Oncolysis and SV-102 in people with Metastatic Castration-resistant Prostate Cancer, run by Syncromune, Inc. at 23 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Partial Oncolysis and SV-102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
23 sitesUnited States
Study dates
29 May 2025to 14 Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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:
  • effective barrier contraception during the treatment period and through 120-150 days after last dose, OR
  • true abstinence, when this is in line with the preferred and usual lifestyle of the participants. Periodic abstinence (for example [e.g.], calendar, ovulation, symptothermal, post ovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.
  • 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.
  • The eligible tumor lesion for intratumoral infusion cannot be a tumor that is adjacent to vital structures such as major nerves or blood vessels or at risk of airway compromise in the event of post-infusion tumor swelling/inflammation.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Central Contact contact

888-636-5344

info@legion100trial.com

www.legion100trial.com contact

23 sites in 1 country

United States23 sites, 23 recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Not yet recruiting

  • Ohio State University

    Columbus, Ohio, 43201

    Recruiting

  • Houston Metro Urology

    Houston, Texas, 77027

    Not yet recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Not yet recruiting

  • Northwell Health

    Lake Success, New York, 11042

    Recruiting

  • Duly Health

    Lisle, Illinois, 60532

    Recruiting

  • Arkansas Urology

    Little Rock, Arkansas, 72211

    Not yet recruiting

  • University of Miami

    Miami, Florida, 33136

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Not yet recruiting

  • Summit Urology

    Murray, Utah, 84107

    Not yet recruiting

  • NYU Langone

    New York, New York, 10016

    Recruiting

  • Weill Cornell

    New York, New York, 10065

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Not yet recruiting

  • Mayo Clinic

    Phoenix, Arizona, 85054

    Not yet recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • University of California-Davis

    Sacramento, California, 95817

    Recruiting

  • Willis Knighton

    Shreveport, Louisiana, 71105

    Not yet recruiting

  • Mercy Hospital

    St Louis, Missouri, 63141

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

  • Michigan Institute of Urology

    Troy, Michigan, 48084

    Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

    Recruiting

  • Wichita Urology

    Wichita, Kansas, 67226

    Recruiting

Other trials in United States

About this study

Official title: 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)

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.

Being tested
Partial Oncolysis, SV-102

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Partial OncolysisProcedure or surgery

    Also called cryolysis

    Partial tumor oncolysis will be completed by cryolysis.

  • SV-102Drug

    Intratumoral infusion of SV-102

Study groups in NCT06533644
Study groupRoleWhat they receive
Part 1 - Dose Escalation, Cohort 1: Partial Oncolysis + SV-102ExperimentalParticipants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 1.
Receives: Procedure: Partial Oncolysis; Drug: SV-102
Part 1 - Dose Escalation, Cohort 2: Partial Oncolysis + SV-102ExperimentalParticipants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 2.
Receives: Procedure: Partial Oncolysis; Drug: SV-102
Part 1 - Dose Escalation, Cohort 3: Partial Oncolysis + SV-102ExperimentalParticipants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 3.
Receives: Procedure: Partial Oncolysis; Drug: SV-102
Part 2 - Dose Optimization, Arm 1: Partial Oncolysis + SV-102ExperimentalParticipants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.
Receives: Procedure: Partial Oncolysis; Drug: SV-102
Part 2 - Dose Optimization, Arm 2: Partial Oncolysis + SV-102ExperimentalParticipants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.
Receives: Procedure: Partial Oncolysis; Drug: SV-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Up to 2 years

  2. Maximum Tolerated Dose

    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).

    Measured: Up to 48 weeks

  3. Optimal Biologic Dose (OBD)

    OBD will be determined based on DLT and dose escalation part data.

    Measured: Up to 48 weeks

  4. Recommended Phase 2 Dose (RP2D)

    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.

    Measured: Up to 48 weeks

  5. Objective Response Rate (ORR)

    The ORR is defined as the percentage of participants who achieved best overall response (BOR) of complete response (CR) or partial response (PR).

    Measured: Up to 2 years

Secondary outcomes (16)

  1. Duration of Response

    The period from the onset of a response (e.g., tumor shrinkage or stabilization) until disease progression or death, whichever occurs first.

    Measured: Up to 2 years

  2. Radiographic Progression-Free Survival (rPFS) per RECIST v1.1 and Prostate Cancer Working Group 3 (PCWG3)

    rPFS is defined as the time from the start of study drug until first documented radiologic disease progression at the first site of disease or death from any cause, whichever comes first.

    Measured: Up to 2 years

  3. Progression-Free Survival (PFS)

    The time interval between the start of treatment and the occurrence of disease progression or death from any cause.

    Measured: Up to 2 years

  4. Overall survival (OS)

    OS is defined as the time from the first dose of study drug to death due to any cause.

    Measured: Up to 2 years

  5. Trough Concentration (Ctrough) of SV-102

    Measured: Pre-infusion at Day 1 of Cycle 1 up to Cycle 12 (each cycle length = 28 days)

  6. Area Under the Concentration Time Curve From Time 0 to the Time t (AUC0-t) of SV-102

    Measured: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)

  7. Area Under the Concentration Time Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of SV-102

    Measured: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)

  8. Maximum Observed Plasma Concentration (Cmax) of SV-102

    Measured: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)

  9. Last Observed (Quantifiable) Concentration (Clast) of SV-102

    Measured: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)

  10. Time to Reach the Maximum Plasma Concentration (Tmax) of SV-102

    Measured: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)

  11. Time of Last Measurable Concentration (Tlast) of SV-102

    Measured: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)

  12. Apparent Terminal Elimination Half-life (T1/2) of SV-102

    Measured: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)

  13. Apparent Total Body Clearance (CL/F) of SV-102

    Measured: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)

  14. Volume of Distribution (Vd) of SV-102

    Measured: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)

  15. Number of Participants With Any Device Constituent Failures/Malfunctions

    Measured: Up to 2 years

  16. Number of Participants With Anti-drug Antibodies (ADA)

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start29 May 2025
  3. Primary completion14 Apr 2028 (estimated)
  4. Study completion14 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Part 1 of the study is a dose escalation design followed by Part 2 randomized, dose optimization design.
Masking
None (open label)
Enrolment
91 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06533644
Sponsor's protocol ID
LEGION-100-2a
Status last verified
Jun 2026
First submitted
30 Jul 2024
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Partial Oncolysis and SV-102 in people with Metastatic Castration-resistant Prostate Cancer, run by Syncromune, Inc. at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Central Contact (888-636-5344, info@legion100trial.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06533644.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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