Actively Recruiting
Phase 1 Trial of SYNC-T - Immunotherapy for Patients With Advanced/Metastatic Solid Tumors
Led by Williams Cancer Foundation · Updated on 2025-04-06
20
Participants Needed
1
Research Sites
152 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
SV-101 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.
CONDITIONS
Official 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 >18 years old at the time of signed informed consent
- Provide written informed consent and be willing to follow treatment and follow-up
- Have advanced or metastatic histologically or cytologically confirmed solid tumor unresponsive to or progressed after standard therapies, or no standard therapy available
- Undergo cardiac work-up and receive cardiac clearance within 2 months before first treatment
- Stop use of anticoagulants or blood thinners (e.g., heparin, warfarin) at least 5 days before each treatment
- Resolution of acute toxic effects (except alopecia) from prior anti-cancer therapy to NCI CTCAE v5 grade ≤ 1
- Measurable disease by RECIST criteria
- Able to undergo general anesthesia or conscious sedation
- Eastern Cooperative Oncology Group (ECOG) performance status less than 3
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study
- Stable bone resorptive therapy doses for at least 42 days before cryolysis if applicable
- No other meaningful life-prolonging therapy options as judged by Investigator
- Adequate bone marrow, renal, and hepatic function as defined by specified laboratory measurements
- All clinically relevant toxicities from prior anticancer therapy recovered to Grade ≤1 or baseline (except alopecia or ototoxicity)
- Female partners of male participants of childbearing potential must use effective contraception during and for 4-5 months after treatment
- At least one lesion visible on PET/CT, CT, Ultrasound, or MRI accessible for injection
You will not qualify if you...
- Known additional progressing malignancy requiring treatment in last 3 years, excluding basal and squamous cell carcinoma
- Major surgery within 28 days before enrollment without adequate recovery
- Active infection requiring systemic therapy, including tuberculosis
- History of non-infectious pneumonitis that required steroids or current pneumonitis
- Live vaccine received within 30 days prior to enrollment
- Participation in other investigational studies or device use within 4 weeks before first treatment
- Tumor volume or disease burden too large for safe or effective treatment
- Metastases limited to subcutaneous regions only
- Significant cardiac or other severe illness (e.g., severe heart failure, unstable angina)
- Malignant pleural effusions or ascites needing immediate intervention
- Prior history of autoimmune disease except hypothyroidism
- Primary or acquired immunodeficiency
- Active COVID infection or positive COVID test on or before planned treatment
- Known or suspected active hepatitis B or untreated hepatitis C infection
- Uncontrolled diabetes, cardiac arrhythmia, hypersensitivity, or other illnesses making participation unsafe as judged by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Diomed
Mexico City, Mexico, 11810
Actively Recruiting
Research Team
J
Jason Williams, MD
CONTACT
E
Eduardo Cortés
CONTACT
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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