NCT06533644ClinicalTrials.gov

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)

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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.

Phase 291 Teilnehmende gesucht23 Studienzentren1 Land

Kategorien

Onkologie68%Nephrologie und Urologie32%

In 1 Register registriert

ClinicalTrials.govNCT06533644Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-08-01; recorded start 2025-05-29
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (Syncromune, Inc.)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 23 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleSMALL

A small study: 91 participants (target), run at 23 sites.

How this score is built

Enrolment18/40
91 participants (target)
Site count16/25
23 sites
Country count0/15
Single country
Planned duration8/10
Planned over about 35 months
Sponsor scale0/10
Syncromune, Inc. has led 1 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

Erkrankungen

Metastatic Castration-resistant Prostate Cancer

Eignung

Eignung
Geschlecht	Männlich
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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 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: 1. effective barrier contraception during the treatment period and through 120-150 days after last dose, OR 2. 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. 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 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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 2
Zuteilung	Randomisiert
Interventionsmodell	SEQUENTIAL
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	91 Teilnehmende gesucht

Sponsor und Mitwirkende

Syncromune, Inc. Sponsor

Studienarme und Interventionen

Part 1 - Dose Escalation, Cohort 1: Partial Oncolysis + SV-102EXPERIMENTAL
Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 1.
Part 1 - Dose Escalation, Cohort 2: Partial Oncolysis + SV-102EXPERIMENTAL
Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 2.
Part 1 - Dose Escalation, Cohort 3: Partial Oncolysis + SV-102EXPERIMENTAL
Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 3.
Part 2 - Dose Optimization, Arm 1: Partial Oncolysis + SV-102EXPERIMENTAL
Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.
Part 2 - Dose Optimization, Arm 2: Partial Oncolysis + SV-102EXPERIMENTAL
Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.

Interventionen

Eingriff Partial Oncolysis
Partial tumor oncolysis will be completed by cryolysis.
Arzneimittel SV-102
Intratumoral infusion of SV-102

Endpunkte

Primärer Endpunkt
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Immune-related Adverse Reactions (imARs)
Zeitrahmen Up to 2 years
Primärer Endpunkt
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).
Zeitrahmen Up to 48 weeks
Primärer Endpunkt
Optimal Biologic Dose (OBD)
OBD will be determined based on DLT and dose escalation part data.
Zeitrahmen Up to 48 weeks
Primärer Endpunkt
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.
Zeitrahmen Up to 48 weeks
Primärer Endpunkt
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).
Zeitrahmen Up to 2 years
Sekundärer Endpunkt
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.
Zeitrahmen Up to 2 years
Sekundärer Endpunkt
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.
Zeitrahmen Up to 2 years
Sekundärer Endpunkt
Progression-Free Survival (PFS)
The time interval between the start of treatment and the occurrence of disease progression or death from any cause.
Zeitrahmen Up to 2 years
Sekundärer Endpunkt
Overall survival (OS)
OS is defined as the time from the first dose of study drug to death due to any cause.
Zeitrahmen Up to 2 years
Sekundärer Endpunkt
Trough Concentration (Ctrough) of SV-102
Zeitrahmen Pre-infusion at Day 1 of Cycle 1 up to Cycle 12 (each cycle length = 28 days)
Sekundärer Endpunkt
Area Under the Concentration Time Curve From Time 0 to the Time t (AUC0-t) of SV-102
Zeitrahmen 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)
Sekundärer Endpunkt
Area Under the Concentration Time Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of SV-102
Zeitrahmen 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)
Sekundärer Endpunkt
Maximum Observed Plasma Concentration (Cmax) of SV-102
Zeitrahmen 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)
Sekundärer Endpunkt
Last Observed (Quantifiable) Concentration (Clast) of SV-102
Zeitrahmen 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)
Sekundärer Endpunkt
Time to Reach the Maximum Plasma Concentration (Tmax) of SV-102
Zeitrahmen 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)
Sekundärer Endpunkt
Time of Last Measurable Concentration (Tlast) of SV-102
Zeitrahmen 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)
Sekundärer Endpunkt
Apparent Terminal Elimination Half-life (T1/2) of SV-102
Zeitrahmen 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)
Sekundärer Endpunkt
Apparent Total Body Clearance (CL/F) of SV-102
Zeitrahmen 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)
Sekundärer Endpunkt
Volume of Distribution (Vd) of SV-102
Zeitrahmen 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)
Sekundärer Endpunkt
Number of Participants With Any Device Constituent Failures/Malfunctions
Zeitrahmen Up to 2 years
Sekundärer Endpunkt
Number of Participants With Anti-drug Antibodies (ADA)
Zeitrahmen Up to 2 years

Daten

Daten
Startdatum	29. Mai 2025 (tatsächlich)
Primärer Abschluss	14. April 2028 (geschätzt)
Abschluss	14. April 2028 (geschätzt)
Erstveröffentlichung	1. August 2024 (tatsächlich)
Zuletzt aktualisiert	23. Juni 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juni 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

14 Studienzentren rekrutieren

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
University of Chicago	Chicago	Illinois	Rekrutierung noch nicht begonnen
Ohio State University	Columbus	Ohio	Rekrutiert
Houston Metro Urology	Houston	Texas	Rekrutierung noch nicht begonnen
Mayo Clinic	Jacksonville	Florida	Rekrutierung noch nicht begonnen
Northwell Health	Lake Success	New York	Rekrutiert
Duly Health	Lisle	Illinois	Rekrutiert
Arkansas Urology	Little Rock	Arkansas	Rekrutierung noch nicht begonnen
University of Miami	Miami	Florida	Rekrutiert
Medical College of Wisconsin	Milwaukee	Wisconsin	Rekrutierung noch nicht begonnen
Summit Urology	Murray	Utah	Rekrutierung noch nicht begonnen
NYU Langone	New York	New York	Rekrutiert
Weill Cornell	New York	New York	Rekrutiert
University of Nebraska Medical Center	Omaha	Nebraska	Rekrutiert
Thomas Jefferson University	Philadelphia	Pennsylvania	Rekrutierung noch nicht begonnen
Mayo Clinic	Phoenix	Arizona	Rekrutierung noch nicht begonnen
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	Rekrutiert
University of California-Davis	Sacramento	California	Rekrutiert
Willis Knighton	Shreveport	Louisiana	Rekrutierung noch nicht begonnen
Mercy Hospital	St Louis	Missouri	Rekrutiert
Moffitt Cancer Center	Tampa	Florida	Rekrutiert
Michigan Institute of Urology	Troy	Michigan	Rekrutiert
University of Arizona Cancer Center	Tucson	Arizona	Rekrutiert
Wichita Urology	Wichita	Kansas	Rekrutiert

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

https://xmedica.io/trials/ctgov/NCT06533644