SYNC-T Therapy for Prostate Cancer

Recruiting at 5 trial locations

Overseen By Central Contact

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Syncromune, Inc.

Must not be taking: Anticoagulants, Blood thinners

Disqualifiers: Other malignancy, Cardiac illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SV-102 for men with advanced prostate cancer. Researchers aim to assess the safety and effectiveness of SV-102 and determine the optimal dose for future studies. Participants will receive a combination of partial oncolysis (a process to break down cancer cells) and SV-102 (SYNC-T Therapy) directly into the tumor. Men with metastatic prostate cancer who have not responded to other treatments may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants receiving bone resorptive therapy must be on stable doses for at least 42 days before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that SYNC-T Therapy SV-102 is generally safe. Early safety data found no serious autoimmune side effects, where the body's defense system mistakenly attacks its own cells. Studies also found that the treatment mostly stays at the tumor site, minimizing its spread to the rest of the body. This localization reduces side effects that affect the whole body.

Overall, previous patients have tolerated the treatment well, with no reports of severe adverse events. Earlier studies suggest that SV-102 is safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard prostate cancer treatments, which often include surgery, radiation, or hormone therapy, SV-102 introduces a novel approach by combining partial oncolysis with an intratumoral infusion. The oncolysis process breaks down tumor cells, which may enhance the delivery and effectiveness of SV-102 directly within the tumor. Researchers are particularly excited about the potential for this targeted method to minimize damage to surrounding healthy tissues while maximizing the anti-cancer effects. This dual-action strategy could lead to more effective and potentially faster responses compared to conventional therapies.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Studies have shown promising results for SYNC-T Therapy SV-102 in treating advanced prostate cancer that no longer responds to hormone therapy. Previous research indicated an 87% overall response rate, meaning most patients saw improvement in their cancer with the treatment. Additionally, more than half of the patients experienced a complete response, where the cancer was no longer detectable. In this trial, participants will receive SYNC-T Therapy, which involves injecting the treatment directly into the tumor to help the body's immune system fight the cancer. Patients have tolerated this method well, with manageable side effects. Overall, the evidence suggests that SYNC-T Therapy SV-102 could be an effective option for this type of prostate cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Charles J Link, MD

Principal Investigator

Syncromune, Inc.

Are You a Good Fit for This Trial?

Men over 18 with advanced prostate cancer that's resistant to castration and has progressed after certain therapies, or when no other standard treatments are available. Participants must have low testosterone if on hormone therapy, be able to handle anesthesia, and have a life expectancy of at least 6 months.

Inclusion Criteria

I have recovered from all side effects of my previous cancer treatments, except for hair loss.

I can sign and follow the study's requirements.

My prostate cancer is advanced, can be measured, and confirmed by tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive partial oncolysis plus an intratumoral infusion of SV-102 at escalating doses to determine the maximum tolerated dose (MTD)

Up to 48 weeks

Dose Expansion

Participants receive partial oncolysis plus an intratumoral infusion of SV-102 at the recommended phase 2 dose (RP2D) determined from the dose escalation phase

Up to 48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including overall survival and progression-free survival

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• SV-102

Trial Overview The trial is testing the safety and tolerability of a new therapy called SV-102 for prostate cancer. It aims to find the highest dose patients can take without serious side effects (MTD) or decide on a dose for future studies.

How Is the Trial Designed?

Group I: Part 2 - Dose Optimization, Arm 2: Partial Oncolysis + SV-102 Experimental Treatment 2 Interventions

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.

Group II: Part 2 - Dose Optimization, Arm 1: Partial Oncolysis + SV-102 Experimental Treatment 2 Interventions

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.

Group III: Part 1 - Dose Escalation, Cohort 3: Partial Oncolysis + SV-102 Experimental Treatment 2 Interventions

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 3.

Group IV: Part 1 - Dose Escalation, Cohort 2: Partial Oncolysis + SV-102 Experimental Treatment 2 Interventions

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 2.

Group V: Part 1 - Dose Escalation, Cohort 1: Partial Oncolysis + SV-102 Experimental Treatment 2 Interventions

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 1.

Who Is Running the Clinical Trial?

Syncromune, Inc.

Lead Sponsor

Trials

3

Recruited

110+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.2504

Clinical responses to SYNC-T therapy: In situ personalized ... Among the 15 subjects, 3 have died resulting in 80% survival with 14 months median follow-up. SYNC-T Therapy was well-tolerated with 41 TEAEs in ...

2. syncromune.com syncromune.com/2025/06/02/syncromune-inc-presents-positive-results-from-sync-t-therapy-sv-102-phase-1-metastatic-prostate-cancer-trial-at-asco-2025/

Syncromune® Inc. Presents Positive Results from SYNC-T ... Final data showed an 87% overall response rate (ORR) and 53% complete response rate (CR) in subjects with metastatic castration resistant prostate cancer ( ...

3. urotoday.com urotoday.com/conference-highlights/asco-2025/asco-2025-prostate-cancer/161019-asco-2025-clinical-responses-to-sync-t-therapy-in-situ-personalized-cancer-vaccination-with-intratumoral-immunotherapy-in-patients-with-mcrpc.html

ASCO 2025: Clinical Responses to SYNC-T Therapy SYNC-T therapy SV-102 for mCRPC demonstrates highly encouraging clinical activity. A significant portion of subjects in this pilot study have ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06533644

NCT06533644 | A Study of SYNC-T Therapy SV-102 in ... Study Details | NCT06533644 | A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer | ClinicalTrials.gov.

5. cancernetwork.com cancernetwork.com/view/oncolysis-immunotherapy-shows-significant-data-in-prostate-cancer

Oncolysis/Immunotherapy Shows 'Significant' Data in ... Prior phase 1 data showed that the treatment produced an objective response rate of 85% among 13 evaluable patients, which included complete ...

6. urotoday.com urotoday.com/recent-abstracts/urologic-oncology/prostate-cancer/162519-syncromune-granted-fda-fast-track-designation-for-sync-t-sv-102-for-the-treatment-of-metastatic-castrate-resistant-prostate-cancer-mcrpc.html

Syncromune Granted FDA Fast-Track Designation for ... Interim data from a Phase 1 study of SV-102 in males with mCRPC demonstrated an overall response rate of 85% with a favorable safety profile and ...