About the LEGION-100 Clinical Trial
A Phase 2a Dose Escalation and Optimization Trial of SYNC-T Therapy SV-102 in Patients Diagnosed With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Criteria to participate
Each clinical trial has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. Deciding to take part in a clinical research trial is an important and personal decision. The trial team will review all aspects of the trial with you and provide a document called an Informed Consent Form (ICF) that has written details about the trial including potential risks and benefits.
You may be eligible if you:
- Have prostate cancer that has spread outside of the prostate and/or to other parts of the body
- Have received prior hormone therapy for your condition
This is not the complete list that is used to determine if you qualify to enroll in the trial and only trial research staff can determine if you are eligible.
Overview of the LEGION-100 clinical trial for metastatic castration-resistant prostate cancer (mCRPC)
Participants in this trial must have advanced prostate cancer that has spread outside of the prostate and/or other parts of the body and is not responding to hormone therapy that lowers testosterone levels.
This clinical trial uses an investigational therapy called SYNC-T SV-102, which is a combination therapy that freezes a portion of a tumor and then infuses a drug directly into the tumor. The therapy is designed to activate the immune system and enable it to fight cancer throughout the body.
The primary purpose of this trial is to evaluate safety, tolerability and the effectiveness of SYNC-T Therapy SV-102 and to identify the optimal dose.
What to expect in LEGION-100 trial participation
The LEGION-100 Phase 2a is a 2-part trial. In Part 1 of the trial, there are three different groups that each receive a different dosage of the SYNC-T Therapy SV-102. This is called a Dose Escalation trial that evaluates the safety, tolerability, and effectiveness of different dosages.
Part 2 of the LEGION-100 Phase 2a will study the 2 most optimal doses from Part 1. This is known as a Dose Optimization trial. Patients will be randomized into one of two groups to study the doses and determine the optimal dose for a Phase 2b trial.
There is no placebo group in this Phase 2a trial. Your safety is our highest priority, and your doctor will review all details, potential side effects, your rights as a patient, and answer questions about any aspect of the trial.
Additionally, the following will be provided at no cost to you:
- Close monitoring of your metastatic prostate cancer and overall health by physicians who are experts in treating prostate cancer
- Reimbursement for some qualified travel and lodging costs
- All study-specific medical exams and imaging.
1 treatment cycle every month for up to 12 total treatments
Frequently Asked Questions
Who is conducting the LEGION-100 Phase 2a trial?
Syncromune is sponsoring and conducting the LEGION-100 prostate cancer clinical trial. We are dedicated to making sure that all patients are represented in our clinical trials. It is important that the therapies we make improve the lives of all people with cancer. Complete trial information can be found on ClinicalTrials.gov.
Why is this trial being conducted?
The primary purpose of this trial to evaluate the safety, tolerability, and effectiveness of SYNC-T Therapy SV-102.
What is an investigational therapy?
An investigational therapy is a drug, device, vaccine, or other treatment that is approved by regulatory agencies (e.g., FDA, EMA) to be studied in clinical trials but has not yet received approval for general use. The therapy is tested for safety, effectiveness, and optimal dosing before they can be marketed to the public.
How does the SYNC-T Therapy work?
Can I leave the LEGION-100 trial after I start?
What happens to my personal information?
The information you provide, imaging, and other medically-related exams will not be shared with anyone who is not directly associated with the LEGION-100 trial without your permission, except as set forth in the informed consent which will be reviewed with you in detail by the clinical trial team.
Expanded Access to Investigational Therapies
Syncromune is an oncology-focused biopharmaceutical company committed to developing therapies that may improve the lives of cancer patients. Our focus centers around conducting clinical research that evaluates the safety and effectiveness of new therapies for patients with solid tumor cancers. Our clinical trial programs are the primary way to get access to a Syncromune investigational therapy. These clinical trials provide the most effective way to assess how our investigational therapies may treat cancer, and are used to support regulatory approval.
At this time, Syncromune does not provide access to investigational therapies outside of clinical trials or prior to regulatory approval. You and your health care provider may learn more about our clinical trials by going to the clinical trials section of our website, or visiting ClinicalTrials.gov and searching for Syncromune.
If you are a health care provider who is interested in learning more about one of our investigational therapies, or a physician with questions about participation in one of our clinical trials, please click here to submit a request. Syncromune will acknowledge your request as soon as possible, typically within 3 days of receipt.
If applicable, this website will be updated with hyperlinks to the relevant expanded access information on ClinicalTrials.gov. Syncromune reserves the right to revise this expanded access policy at any time.
Pursuant to the 21st Century Cures Act, the posting of policies by manufacturers and distributors shall not serve as a guarantee of access to any specific investigational therapy by any individual.