Actively Recruiting
Phase 1 Trial of SYNC-T Immunotherapy Given After Controlled Cellular Lysis for Patients With Advanced/Metastatic Solid Tumors
Led by Williams Cancer Foundation · Updated on 2025-04-06
20
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
W
Williams Cancer Foundation
Lead Sponsor
S
Syncromune, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate SV-101, a combination immunotherapy designed to overcome the complex mechanisms that allow tumors to evade the immune system. The trial focuses on patients with advanced or metastatic solid tumors, including metastatic breast and lung cancers, for whom standard treatments have failed or are unavailable. The study is a Phase 1 clinical trial assessing the safety and antitumor activity of this regimen. Participants receive SV-101, which is studied for its multiple immune-related effects against tumors. This treatment is given after a controlled cellular lysis procedure to maximize immune response. The trial includes one treatment arm where patients are monitored over time to assess the therapy's impact. Treatment is administered under medical supervision, and patients must meet specific health and safety criteria before starting. During the study, participants will undergo evaluations such as imaging scans to measure tumor response, blood tests to monitor organ function, and assessments for adverse events over a one-year period. Researchers will track antitumor activity about 4 to 6 weeks after each treatment. Safety is closely monitored throughout, including serious side effects and reasons for stopping treatment. The total study duration includes regular follow-up visits to ensure comprehensive data collection and participant well-being.
CONDITIONS
Brief Title
Phase 1 Trial of SYNC-T - Immunotherapy for Patients With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged over 18 years at the time of informed consent
- Willing to provide written informed consent and adhere to treatment and follow-up
- Have advanced and/or metastatic solid tumor confirmed by histology or cytology
- Have no response or progression after standard therapies or no available standard therapy
- Underwent cardiac work-up and received clearance within 2 months before treatment
- Stopped anticoagulants or blood thinners at least 5 days before each treatment
- Resolved acute toxic effects from prior cancer therapy to grade 1 or less
- Have measurable disease by RECIST criteria
- Able to undergo general anesthesia or conscious sedation
- ECOG performance status less than 3
- Women of childbearing potential must have negative pregnancy test within 7 days prior
- Stable doses of bone resorptive therapy for at least 42 days before cryolysis
- Investigator agrees no other meaningful life-prolonging therapy is available
- Adequate bone marrow, renal, and hepatic function as defined by specific lab values
- All toxicities related to prior anticancer therapy recovered to grade 1 or baseline
- Female partners of participants of childbearing potential must use effective contraception during and 4-5 months after treatment
- At least one lesion accessible for injection and visible on imaging
You will not qualify if you...
- Known additional progressing malignancy or requiring active treatment in last 3 years (except basal or squamous cell carcinoma)
- Major surgery within 28 days prior to enrollment without adequate recovery
- Active infection requiring systemic therapy
- History of pneumonitis requiring steroids or current pneumonitis
- Live vaccine within 30 days prior to enrollment
- Participation in another investigational agent or device study within 4 weeks prior
- Tumor volume or disease burden too large for safe or effective treatment
- Metastases limited only to subcutaneous regions (skin only)
- Significant cardiac or medical illness such as severe heart failure or unstable angina
- Malignant pleural effusions or ascites requiring immediate intervention
- Prior autoimmune disease except hypothyroidism
- Primary or acquired immunodeficiency
- Active COVID infection or positive test day before or day of treatment
- Active hepatitis B or untreated hepatitis C infections
- Other illnesses or conditions making the participant a poor candidate as judged by investigators with medical officer consultation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 4 to 6 week cycles until disease progression or discontinuation
Participants receive the SYNC-T immunotherapy drug SV-101 after controlled cellular lysis to treat advanced or metastatic solid tumors.
Visits approximately every 4 to 6 weeks for treatment and assessment
Duration - Up to 1 year from baseline
Participants are monitored for adverse events and safety for up to 1 year after starting treatment.
Regular visits throughout the follow-up period
Trial Site Locations
Total: 1 location
1
Hospital Diomed
Mexico City, Mexico, 11810
Actively Recruiting
Research Team
J
Jason Williams, MD
E
Eduardo Cortés
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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