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INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases
NCT07172282 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Nelitolimod
Study Locations (1)
New York
- RJ Zuckerberg — Lake Success
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-11-17 |
| Est. Completion | 2028-11-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07172282
The ClinicalTrials.gov registry entry for NCT07172282 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 371 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Colorectal Cancer Metastatic appearing as the primary indexed condition, and to 1 intervention — of which Nelitolimod is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07172282 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07172282 about?
NCT07172282 is a clinical study titled "INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases". 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 CR...
What is the current status of trial NCT07172282?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2025-11-17. Estimated completion is 2028-11-01.
What conditions does trial NCT07172282 study?
This clinical trial studies the following conditions: Colorectal Cancer Metastatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07172282?
The interventions under investigation include: Nelitolimod (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07172282?
This trial is sponsored by Northwell Health, which has 371 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07172282 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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