LEGION-100: A Phase 2a Dose Escalation and Optimization trial of SYNC-T Therapy SV-102 in Patients Diagnosed With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Overview of the LEGION-100 clinical trial for metastatic castration-resistant prostate cancer (mCRPC)
The LEGION-100 Phase 2a clinical trial is studying an investigational therapy 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. Further details about participation eligibility can be found here. Â
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.Â
The primary purpose of this trial is to evaluate the safety, tolerability and effectiveness of SYNC-T Therapy SV-102 and to identify the optimal dose.Â
- Study Details
MEDICAL CONDITION
Metastatic Castration-Resistant Prostate Cancer
SEX
Male
CLINICALTRIALS.GOV ID NUMBER
NCT06533644
STUDY PHASE
Phase 2a
STUDY TYPE
Interventional
INVESTIGATIONAL THERAPY
SYNC-T Therapy SV-102
- Criteria to participate
Age
18 Years +
Sex
Male
Healthy Volunteers
No
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.Â
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.
- Process To Determine If You Are A Candidate
- Â Answer a short questionnaire
If you think you may be a candidate for the LEGION-100 trial, the first step is to answer a short online questionnaire about your diagnosis and medical history. Your answers will be reviewed by the Syncromune clinical trial team to assess if you might be a good fit for the trial.
2. Speak with a clinical trial expert
If you are determined to be a potential candidate after the online questionnaire, and you choose to share your contact information with the study team, a team member will contact you to discuss your medical history, provide additional details about the trial, and potentially schedule imaging and other tests to confirm your eligibility.
3. A trial expert will confirm your eligibility
After speaking with a trial expert, if you are a potential candidate, you will be scheduled for tests that are performed in the last phase of screening. Your answers, medical imaging, and other tests are strictly confidential and if you choose to share information with the trial team it will only be utilized to confirm your eligibility. Only the trial team can determine if you meet the participation criteria and are able to enroll in the study.
- Who is involved with the LEGION-100 trial?
Trial Team
Members of the Syncromune Team, investigators, and clinical sites who support participants and the trial
Principal Investigators
Researchers who are responsible for conducting the trial at their respective trial site
Trial Site
The facility where the trial treatment takes place that may include a hospital, outpatient clinic, or similar facility
Review Boards
Depending on the facility and location, Ethics Review Boards (ERBs) and Internal Review Boards (IRBs) protect participants by ensuring the trial is ethical and fair
Trial Sponsor
Syncromune is the sponsor of the LEGION-100 trial and responsible for initiation and completion of the trial.
Safety Review Committee
Safety review committees (SRCs) are responsible for monitoring the safety of participants in clinical trials and making decisions about how the trial progresses.
Trial Team
Members of the Syncromune Team, investigators, and clinical sites who support participants and the trial
Principal Investigators
Researchers who are responsible for conducting the trial at their respective trial site
Trial Site
The facility where the trial treatment takes place that may include a hospital, outpatient clinic, or similar facility
Review Boards
Depending on the facility and location, Ethics Review Boards (ERBs) and Internal Review Boards (IRBs) protect participants by ensuring the trial is ethical and fair
Trial Sponsor
Syncromune is the sponsor of the LEGION-100 trial and responsible for initiation and completion of the trial.
Safety Review Committee
Safety review committees (SRCs) are responsible for monitoring the safety of participants in clinical trials and making decisions about how the trial progresses.
- 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 different dosages.Â
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
Treatments
1 treatment cycle every month for up to 12 total treatments
Length of trial
Up to 5 years
Location
Multiple locations throughout the U.S.
- Your Questions Answered
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.
The primary purpose of this trial is to evaluate the safety, tolerability and effectiveness of SYNC-T Therapy SV-102.
An investigational therapy is a 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 received approval for general use. The therapy is tested for safety, effectiveness, and optimal dosing before it can be marketed to the public.
The SYNC-T Therapy is an entirely new approach to treating metastatic solid tumor cancers. It is an in situ (within the body) personalized therapy that combines freezing of a portion of a tumor followed by the infusion of a drug directly into the tumor. The goal is to activate the immune system and combat cancer in several different ways. This combination approach is designed to empower your immune system to recognize and attack cancer throughout the body.Â
Yes, taking part in any clinical trial is completely voluntary. If you decide to take part, you are free to withdraw at any time, for any reason, and without any penalty or effect on your future medical care. If you decide to leave the LEGION-100 trial, you should talk to your physician about next steps.
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.
- LEGION-100 Trial Locations
Please check back often, as additional trial sites may be added.
Recruiting
Wynnewood, Pennsylvania, 19096
Recruiting
Troy, Michigan, 48084
Recruiting
Tucson, Arizona, 85724, United States
Resources for Additional Information
Resources for Additional Information
There are numerous prostate cancer advocacy groups and other cancer resources that provide extensive information about the disease, cancer in general, current treatment options based on cancer stage, and support groups designed to help patients and caregivers. For your reference, below is a list of of some organizations along with links to their websites
There are numerous prostate cancer advocacy groups and other cancer resources that provide extensive information about the disease, cancer in general, current treatment options based on cancer stage, and support groups designed to help patients and caregivers. For your reference, below is a list of of some organizations along with links to their websites
For Prostate Cancer
General Cancer Resources
For Prostate Cancer
- 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 submit a request to trials@syncromune.com. 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.
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