Background
Metastatic castration-resistant prostate cancer (mCRPC) is prostate cancer that has spread to other parts of the body and continues to grow despite very low testosterone levels. While several treatments are available, new and more effective therapies are still needed.
SYNC‑T Therapy SV‑102 in a Phase 2 Clinical Study (LEGION-100) for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Why Is This Study Being Done?
The LEGION100 study is evaluating an investigational treatment called SYNCT Therapy SV102 for men with mCRPC. The main goals of this study are to assess safety (understand side effects) and overall response rate (the percentage of participants whose tumors shrunk on imaging scans). Additional goals include measuring how quickly the tumor responds to treatment, how long responses last, and overall survival (OS). ‑100‑T Therapy SV‑102
How the Therapy Works
SYNC‑T Therapy is a simple outpatient procedure that involves placing a needle-like device into the tumor using image guidance (CT or ultrasound) followed by infusion directly into the tumor of the study drug (SV-102), which is a combination of four cancer drugs that help the immune system fight cancer throughout the body and at the treated tumor site. The procedure involves 2 steps:
- A needle-like device is inserted into the center of the tumor to freeze a portion of the tumor cells and break them open to release proteins that help your immune system recognize the cancer.
- Immediately afterwards, the same needle-like device is used to infuse the study drug, SV-102, directly into the same tumor area that was frozen.
Together, the combination of breaking open tumor cells and then infusing SV-102 can activate your immune system and educate it to recognize and attack cancer throughout your entire body.
Study Design
This Phase 2 study has two parts. All participants in the study will receive SYNC-T Therapy SV-102 (no placebo).
- Part 1: Three dose levels to evaluate safety (dose escalation).
- Part 2: Two selected dose levels chosen from Part 1 to determine the most appropriate dose for future studies (dose optimization). Patients are randomly placed into one of the two dose groups.
Approximately 70 participants are expected to enroll in the clinical study.
Who Can Participate?
- Men aged 18 or older with mCRPC
- Have received at least one prior hormone-based therapy (a second-generation androgen receptor medicine), with or without prior taxane chemotherapy‑based therapy (a ‑receptor medicine), with or without prior taxane chemotherapy
- Have at least one tumor that doctors can safely reach for freezing and infusion of the study drug
- Can safely have anesthesia or sedation
- Have an acceptable daily activity level
- A life expectancy of at least 6 months
Some reasons a person may not be eligible include:
- Cancer spread to certain organs, such as the liver
- Active infections or some immune conditions
- Certain bleeding risks or use of specific blood thinners
- Recent major surgery
These are not all of the participation criteria and final determination will be confirmed by the clinical study team.
What Participation May Involve
- Visit the study site for treatment every four weeks for up to 12 treatments.
- Regular clinic visits, physical exams, and imaging scans are required.
- An on-treatment tumor biopsy is required as part of the study treatment. ‑treatment
- The study may follow patients for up to 5 years.
- Study-related tests are covered, and some travel or lodging costs may be reimbursed.
Results So Far (Phase 1 Study)
In a completed Phase 1 study involving 15 participants, Syncromune reported:
- Most side effects were mild to moderate and resolved quickly, and no severe side effects were reported.
- Majority of study participants (87%) demonstrated a therapeutic response to SYNC-T Therapy SV-102.
- More than half of the participants (53%) had no detectable cancer after treatment.
- On average, participants who responded to treatment did not see their cancer grow or return for approximately 14.2 months.
- These early results need to be confirmed in larger studies.
Possible Benefits & Risks
Potential Benefits: SYNC-T Therapy SV-102 may provide more time without cancer worsening and may shrink tumors to the point that they are no longer detectable under imaging such as a CT, MRI, or bone scan. The previous clinical study reported that the therapy was well-tolerated, with the most common side effects being hematuria (presence of blood in the urine) and fever, which were manageable and resolved after treatment.
Potential Risks: While no severe side effects have been previously reported, the therapy is still under investigation, and potential risks may include (but not limited to) pain or swelling at the treatment site, rare immune overaction, procedure-related complications such as trouble urinating, and unknown long-term risks.
Organization:
- Syncromune, Inc.
- Syncromune, Inc. For additional information: legion100trial.com
ClinicalTrials.gov Information
- NCT Number: NCT06533644
- Title: A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer
Use the “clinical trials glossary” and “dictionary” for words, phrases, and treatments that you may not understand.
Register your interest or comments about this trial with PHEN
Please note: This information is provided for educational and awareness purposes. A decision on clinical trial participation is to be made between the patient and his doctor.
Glossary of Key Terms
Biopsy: A medical procedure in which a small sample of tissue is taken from the body so doctors can examine it more closely. In this study, a biopsy is taken from the tumor to help researchers understand how the treatment is working.
Bone Scan: A bone scan is an imaging test that helps doctors see if cancer has spread to the bones or if there are other bone problems. A small amount of a safe radioactive substance is injected into a vein, and a special camera takes pictures of the bones. Areas with abnormal activity may appear brighter on the scan
CT Scan (Computed Tomography): A type of imaging test that uses X-rays to create detailed pictures of the inside of the body. CT scans help doctors see tumors and guide the treatment procedure
Dose Escalation: A process in a clinical study where the amount of a study drug is slowly increased in different groups of participants to find a safe dose.
Dose Optimization: The part of a study that helps determine which dose works best while still being safe for patients.
Hematuria: The presence of blood in the urine. This can sometimes happen after procedures involving the urinary system.
Immune System: The body’s natural defense system that helps fight infections and diseases, including cancer.
Investigational Treatment: A treatment that is still being studied and has not yet been approved by the U.S. Food and Drug Administration (FDA).
LEGION-100 Trial: The LEGION-100 trial is a Phase 2 clinical study testing an investigational treatment called SYNC-T Therapy SV-102 for men with metastatic castration-resistant prostate cancer (mCRPC). The study is designed to evaluate the safety of the treatment, understand possible side effects, and measure how well it works in shrinking tumors and slowing cancer growth
MRI (Magnetic Resonance Imaging: An MRI is an imaging test that uses a strong magnet and radio waves to create detailed pictures of the inside of the body. It does not use radiation. MRI scans help doctors see organs and tumors clearly and monitor how a disease or treatment is affecting the body.
Metastatic Castration-Resistant Prostate Cancer (mCRPC): A form of prostate cancer that has spread to other parts of the body and continues to grow even when testosterone levels are very low.
Phase 2 Clinical Study: A type of clinical trial that focuses on how well a treatment works and continues to monitor safety in a larger group of participants.
Primary Tumor: The primary tumor is the original tumor where the cancer first started in the body.
SYNC-T Therapy: An investigational treatment that combines freezing part of a tumor and delivering immune-activating drugs directly into the tumor to help the body recognize and fight cancer.
SV-102: The study drug used in this trial. It contains a combination of four cancer-fighting drugs designed to activate the immune system.
