RecruitingEarly Phase 1NCT07172282

INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases

Sponsor

Northwell Health

Enrollment

10 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Metastatic

Summary

Nelitolimod is a classC toll-like receptor 9 (TLR9) agonist that binds to TLR9 receptors on myeloid-derived suppressor cells(MDSCs) and helps reshape the tumor microenvironment (TME) and promote antitumor immunity. Investigators hypothesize that Nelitolimod can induce antitumor immune response in CRLM when administered regionally to the liver via a TriNav Pressure Enabled Drug Delivery (PEDD) catheter without compromising surgical feasibility or patient safety. The study objective is to investigate the feasibility and safety of an innovative immunotherapeutic approach for patients with CRLM designed to overcome the immunosuppressive TME in CRLM. Investigators hypothesize that this investigational neoadjuvant treatment will be well tolerated and will not prevent patients from undergoing successful, safe CRLM liver resections. Investigators will assess the safety and feasibility of Nelitolimod given via TriNav PEDD in 10 patients with CRLM prior to liver resection. Patients will receive standard treatment with chemotherapy and then undergo placement of the PEDD catheter. Patients will then receive 3 doses of Nelitolimod before undergoing liver resection.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (INFINITIVE) is studying whether adding immunotherapy (a drug that helps the immune system fight cancer) before and after surgery to remove colorectal cancer that has spread only to the liver improves outcomes compared to surgery and chemotherapy alone. **You may be eligible if...** - You are 18 or older with confirmed colorectal cancer that has spread only to your liver (liver-limited metastases) that can be surgically removed - Your cancer is the type that does not respond well to standard immunotherapy (called pMMR/MSS) - You are in good physical condition (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has spread to other organs beyond the liver - Your cancer is not resectable (cannot be removed surgically) - You have active autoimmune disease or a history of severe immune reactions - You have active hepatitis B, hepatitis C, or HIV - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNelitolimod

Nelitolimod drug product is a clear to slightly opalescent, colorless to pale yellow solution free of visible particles and is supplied by TriSalus to the study sites in single-use vials. One vial is to be used per patient, and each vial should be discarded immediately after use.