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NCT07172282 · ClinicalTrials.gov registry record · Early Phase 1

INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases

A Early Phase 1 study of Colorectal Cancer Metastatic, sponsored by Northwell Health.

Recruiting
Registry status
Early Phase 1
Development phase
10
Enrollment target
1
Study location

NCT07172282 is a Early Phase 1 study of Colorectal Cancer Metastatic that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 10 participants, below the 205-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07172282, a Early Phase 1 study of Colorectal Cancer Metastatic, is actively recruiting participants, sponsored by Northwell Health.

RECRUITING
Registry status
Early Phase 1
Development phase
10 participants
Enrollment target
1
Study location

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.

Interventions

  • DRUG Nelitolimod

Study Locations (1)

New York

  • RJ Zuckerberg - Lake Success

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2025-11-17
Est. Completion 2028-11-01
Phase Early Phase 1

Sponsor

Northwell Health

370 total trials

What the Registry Record Tells You About NCT07172282

The ClinicalTrials.gov registry entry for NCT07172282 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (95% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.

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.

NCT07172282 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

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.

What interventions are being tested in trial NCT07172282?

The interventions under investigation include: Nelitolimod (DRUG).

Who is sponsoring clinical trial NCT07172282?

This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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