Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Early Phase 1 study of Colorectal Cancer Metastatic, sponsored by Northwell Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess the feasibility of neoadjuvant treatment with Nelitolimod delivered via PEDD in CRLM followed by surgical resection. Feasibility will be defined as at least 8 of 10 patients receiving surgery in a timely fashion (2-6 weeks). Enrollment will be stopped if 3 patients do not receive surgery in a timely fashion, irrespective of the number of patients enrolled. This is a safety and feasibility study for patients who as part of standard of care undergo 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 |
What NCT07172282 shows while recruiting
NCT07172282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 205-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer Metastatic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07172282's enrollment target sits among peer trials
10 17th of 18 higher than 1 of 18 other Colorectal Cancer Metastatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer Metastatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
RECRUITING · Early Phase 1
-
Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)
RECRUITING · Phase 2
-
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases
RECRUITING
-
Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection
RECRUITING
-
Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer
RECRUITING · Phase 2
-
Pilot Study for Colorectal Cancer and Advanced Adenoma Detection With the Mainz Biomed Colorectal Cancer Test
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00623389 · 10 participants · NA
Evaluation of an Advanced Lower Extremity Neuroprostheses
- NCT01241864 · 10 participants · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
- NCT01293214 · 10 participants · NA
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
- NCT01474148 · 10 participants · NA
A Neuroprosthesis for Seated Posture and Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI