Phase 1 Trial of SYNC-T - Immunotherapy for Patients With Advanced/Metastatic Solid Tumors
This study tests a new immunotherapy treatment called SYNC-T designed to help the body's immune system fight advanced cancers that have spread. The treatment combines multiple drugs that work together to overcome the ways cancer cells hide from the immune system.
Key Objective:The trial is testing whether this combination immunotherapy can help shrink or slow the growth of advanced solid tumors.
Who to Consider:Patients with advanced or metastatic solid tumors who have limited other treatment options may want to consider enrolling.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female, aged \>18 years old at the time of signed informed consent 2. Provide written informed consent and must be willing to adhere with treatment and follow-up. 3. Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available. 4. Meet all eligibility criteria 5. Has undergone a cardiac work-up and received cardiac clearance two months before first treatment 6. Has halted use of any anticoagulants or other blood thinners (including but not limited to heparin or warfarin) within five (5) days of each treatment. 7. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v5 grade ≤ 1. 8. Measurable disease by RECIST. 9. Able to undergo general anesthesia or conscious sed