Metastatic Castration-resistant Prostate CancerPhase 1NCT05544227
Phase 1 Trial of SYNC-T - Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study testing SV-102 in people with Metastatic Castration-resistant Prostate Cancer, run by Williams Cancer Foundation at 1 site in Mexico.
Trial summary
SV-102 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- SV-102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2023to 1 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 at the time of signed informed consent
- Provide written informed consent
- Subjects with advanced and/or metastatic histologically or cytologically confirmed castrate-resistant prostate cancer
- After failure after the receipt of previous treatment with one or more approved second-generation androgen-receptor-pathway inhibitors and with or without a prior course of taxanes therapy or those with metastatic prostate cancer who have refused hormone therapy and chemotherapy, or have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available
- Patients who may or may not have had prior therapy with Lutetium Lu-177-PSMA-I\&T
- Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v5 grade ≤ 1.
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- Measurable disease by RECIST.
- Meet all eligibility criteria
- Able to undergo general anesthesia or conscious sedation
- Has undergone a cardiac work-up and received cardiac clearance two months before first treatment
- Has halted use of any anticoagulants or other blood thinners (including but not limited to heparin or warfarin) within five (5) days of each treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of < 3 (0, 1, or 2)
- All subjects with female partners of childbearing potential must use effective contraception throughout study treatment and for 120-150 days (4-5 months) after the last dose of study intervention
- Has at least one lesion within the prostate accessible transperineally using transrectal ultrasound (TRUS) that is demonstrable on PET/CT, CT, Ultrasound, or MRI and is accessible for infusion on TRUS or, if a radical prostatectomy has been performed, has a metastatic lesion or lymph node lesion that is demonstrable on PET/CT, CT, or MRI and accessible by a percutaneous needle to permit treatment.
- Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must be on stable doses for at least 42 days prior to the cryolysis
- Adequate bone marrow, renal, and hepatic function, defined as follows:
- Bone marrow function without transfusion 30 days before first dosing: i. Absolute neutrophil count ≥ 1.5 x 109/L; Lymphocyte count of ≥ 1.0 x 109/L; Platelet count ≥ 100 x 109/L; ii. Hemoglobin ≥ 9.0 g/dL b. Renal function" i. Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or creatinine clearance calculated by Cockcroft-Gault equation ≥30 mL/ c. Hepatic function i. Alanine aminotransferase ≤ 3x upper limit of normal (ULN) ii. Aspartate aminotransferase ≤ 3x ULN iii. Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in subjects with documented Gilbert's Syndrome iv. Patients with liver metastases ≤5x ULN
- All clinically relevant toxicities related to prior anticancer therapy must have recovered to Grade ≤1 or baseline (except alopecia or ototoxicity
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 drug and has not recovered adequately from the toxicities and/or complications
- Has an active infection (including tuberculosis) requiring systemic therapy
- Has a history of non-infectious pneumonitis that required 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 treatment
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- 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
- Malignant pleural effusions or ascites that require immediate intervention
- Prior history of autoimmune disease except hypothyroidism, uncontrolled or unmanaged diabetes, cardiac arrhythmia (unstable or untreated), hypersensitivity, or other illness or disease that in the opinion of the Principal Investigator, with consultation with Syncromune's Chief Medical Officer, makes the subject a poor candidate.
- Any primary or acquired immunodeficiency
- Active COVID infection or tests positive for COVID day before or day of planned treatment
- Known or suspected hepatitis B if active infection (subjects with chronic hepatitis B infection must have an undetectable Hepatitis B virus (HBV) viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion)
- Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load
- Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study drug, interfere with subject compliance or conduct of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunotherapy Regimen Given After Targeted Local Cryolysis (TLC) for Patients With Advanced/Metastatic Castration-resistant Prostate Cancer (mCRPC) OR Those With Metastatic Prostate Cancer Who Refused Hormone Therapy and Chemotherapy.
SV-102 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.
Read the detailed description
SV-102 is intended for immunotherapeutic treatment of solid tumors in certain metastatic cancer indications. SYNC-T™ technology encompasses methods and compositions that mediate multiple pharmacologic effects aimed at mounting a synchronized and multi-faceted antitumor immune response. The first component of SYNC-T™ is aimed at eliciting in situ immunization by triggering the lysis and immunogenic cell death of tumor cells, followed by the release of tumor-specific or tumor-associated antigens (TSA/TAAs) and danger associated molecular patterns (DAMPs) into the tumor microenvironment. The main approach that will be used by SYNC-T™ will rely on partial and targeted local cryolysis of tumor cells mediated by a cryolysis device. The second component of SYNC-T™ technology is the intratumoral infusion of a low-dose multi-component drug product.
- Being tested
- SV-102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SV-102Drug
SV-102 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immunopharmacologic effects.
| Study group | Role | What they receive |
|---|---|---|
| SV-102 Treatment Arm | Experimental | SV-102 Treatment Arm Receives: Drug: SV-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Summary of treatment-emergent AEs, including NCI CTCAE v5.0 severity grade and relationship to either the device or study drugs.
Measured: Baseline through 30 days after end-of-treatment
Number of participants with deaths
Summary of deaths leading to study discontinuation
Measured: Baseline through 30 days after end-of-treatment
Number of participants with treatment-emergent SAEs and AEs
Summary of treatment-emergent SAEs, and AEs leading to study discontinuation
Measured: Baseline through 30 days after end-of-treatment
Assessment of laboratory values.
Summary of laboratory values over time and shifts in laboratory measurements by NCI CTCAE v5.0 grade.
Measured: Baseline through 30 days after end-of-treatment
Secondary outcomes (6)
Number of patients in the Intent-to-Treat Population with complete response to SV-102.
Summary of objective response rate (ORR), presented as the percentage of patients with a complete response as assessed by the Investigator using PCWG3.
Measured: Baseline through 12 weeks after end-of-treatment
Number of patients in the Intent-to-Treat Population with complete response to SV-102.
Summary of objective response rate (ORR), presented as the percentage of patients with a complete response as assessed by the Investigator using RECIST 1.1.
Measured: Baseline through 12 weeks after end-of-treatment
Number of patients in the Intent-to-Treat Population with complete response to SV-102.
Summary of objective response rate (ORR), presented as the percentage of patients with a complete response as assessed by the Investigator using iRECIST.
Measured: Baseline through 12 weeks after end-of-treatment
Number of patients in the Intent-to-Treat Population with partial response to SV-102.
Summary of objective response rate (ORR), presented as the percentage of patients with a partial response as assessed by the Investigator using PCWG3.
Measured: Baseline through 12 weeks after end-of-treatment
Number of patients in the Intent-to-Treat Population with partial response to SV-102.
Summary of objective response rate (ORR), presented as the percentage of patients with a partial response as assessed by the Investigator using RECIST 1.1.
Measured: Baseline through 12 weeks after end-of-treatment
Number of patients in the Intent-to-Treat Population with partial response to SV-102.
Summary of objective response rate (ORR), presented as the percentage of patients with a partial response as assessed by the Investigator using iRECIST.
Measured: Baseline through 12 weeks after end-of-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Feb 2023
- Primary completion10 Dec 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Williams Cancer Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Syncromune, Inc.
- Responsible party
- Principal investigator, Carlos Vargas, MD, Williams Cancer Foundation
- Investigators
- Carlos Vargas, MD, Principal investigator, Williams Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544227
- Sponsor's protocol ID
- Phase 1 SV-102
- Status last verified
- Apr 2025
- First submitted
- 16 Aug 2022
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy Regimen Given After Targeted Local Cryolysis (TLC) for Patients With Advanced/Metastatic Castration-resistant Prostate Cancer (mCRPC) OR Those With Metastatic Prostate Cancer Who Refused Hormone Therapy and Chemotherapy.
- ClinicalTrials.gov ID
- NCT05544227
- Acronym / sponsor ID
- Phase 1 SV-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Williams Cancer FoundationUniversity, hospital or other
- Collaborators
- Syncromune, Inc.
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SV-102 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.
Detailed description
SV-102 is intended for immunotherapeutic treatment of solid tumors in certain metastatic cancer indications. SYNC-T™ technology encompasses methods and compositions that mediate multiple pharmacologic effects aimed at mounting a synchronized and multi-faceted antitumor immune response. The first component of SYNC-T™ is aimed at eliciting in situ immunization by triggering the lysis and immunogenic cell death of tumor cells, followed by the release of tumor-specific or tumor-associated antigens (TSA/TAAs) and danger associated molecular patterns (DAMPs) into the tumor microenvironment. The main approach that will be used by SYNC-T™ will rely on partial and targeted local cryolysis of tumor cells mediated by a cryolysis device. The second component of SYNC-T™ technology is the intratumoral infusion of a low-dose multi-component drug product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SV-102 Treatment Arm | Experimental | Drug: SV-102SV-102 Treatment Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male >18 years old at the time of signed informed consent
- Provide written informed consent
- Subjects with advanced and/or metastatic histologically or cytologically confirmed castrate-resistant prostate cancer
- After failure after the receipt of previous treatment with one or more approved second-generation androgen-receptor-pathway inhibitors and with or without a prior course of taxanes therapy or those with metastatic prostate cancer who have refused hormone therapy and chemotherapy, or have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available
- Patients who may or may not have had prior therapy with Lutetium Lu-177-PSMA-I\&T
Key exclusion criteria (14 listed)
- 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 drug and has not recovered adequately from the toxicities and/or complications
- Has an active infection (including tuberculosis) requiring systemic therapy
- Has a history of non-infectious pneumonitis that required steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SV-102SV-102 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immunopharmacologic effects. | Drug | SV-102 Treatment Arm |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: Baseline through 30 days after end-of-treatment
Summary of treatment-emergent AEs, including NCI CTCAE v5.0 severity grade and relationship to either the device or study drugs.
Number of participants with deaths
Time frame: Baseline through 30 days after end-of-treatment
Summary of deaths leading to study discontinuation
Number of participants with treatment-emergent SAEs and AEs
Time frame: Baseline through 30 days after end-of-treatment
Summary of treatment-emergent SAEs, and AEs leading to study discontinuation
Assessment of laboratory values.
Time frame: Baseline through 30 days after end-of-treatment
Summary of laboratory values over time and shifts in laboratory measurements by NCI CTCAE v5.0 grade.
6 secondary outcomes
Number of patients in the Intent-to-Treat Population with complete response to SV-102.
Time frame: Baseline through 12 weeks after end-of-treatment
Number of patients in the Intent-to-Treat Population with complete response to SV-102.
Time frame: Baseline through 12 weeks after end-of-treatment
Number of patients in the Intent-to-Treat Population with complete response to SV-102.
Time frame: Baseline through 12 weeks after end-of-treatment
Number of patients in the Intent-to-Treat Population with partial response to SV-102.
Time frame: Baseline through 12 weeks after end-of-treatment
Number of patients in the Intent-to-Treat Population with partial response to SV-102.
Time frame: Baseline through 12 weeks after end-of-treatment
Number of patients in the Intent-to-Treat Population with partial response to SV-102.
Time frame: Baseline through 12 weeks after end-of-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration-resistant Prostate Cancer
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Vargas, MD principal investigator
Williams Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SV-102 in people with Metastatic Castration-resistant Prostate Cancer, run by Williams Cancer Foundation at 1 site in Mexico.
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 18 inclusion and 14 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: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. (time frame: Baseline through 30 days after end-of-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2025.