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Colorectal Cancer MetastaticEarly Phase 1NCT07172282

INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases

A Early Phase 1 study testing Nelitolimod in people with Colorectal Cancer Metastatic, run by Northwell Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Nelitolimod
How many people
10 participants
Where
1 siteUnited States
Study dates
17 Nov 2025to 1 Nov 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. A signed informed consent must be obtained prior to conducting any study-specific procedures.
  • Male or female adults 18 years of age or older on day of signing informed consent.
  • Radiographically confirmed metastatic adenocarcinoma to the liver from a colon or rectum primary tumor that is amenable to resection. TXNXM1+
  • Only participants with liver-limited, resectable metastatic disease are eligible for participation (ablations are allowed to achieve an R0 intention-to-treat outcome).
  • Only participants with pMMR (mismatch repair-proficient)/MSS mCRC are eligible. Microsatellite status should be performed according to the local standard of practice. (e.g., immunohistochemistry [IHC] and/or polymerase chain reaction [PCR], next-generation sequencing). Subjects with unknown or indeterminant results for either test at the time of enrollment are not eligible at investigators discretion.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
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  • Patients with synchronous disease who are planned to undergo liver and resection of primary are allowed.
  • Total neoadjuvant therapy (TNT) for rectal cancers allowed.
  • In the event the patient has had prior oxaliplatin-based adjuvant chemotherapy after resection of primary tumor, a minimum interval of 6 months should have passed prior to enrollment into the study.
  • Patients must have completed standard of care FOLFOX/ FOLFIRI/FOLFIRINOX as part of pre- operative systemic therapy.
  • Meets resectability criteria (all criteria MUST be met):
  • Tumors that can be resected completely (R0), while leaving an adequate future liver remnant (defined under c.)
  • The ability to preserve two contiguous hepatic segments with preservation of adequate vascular inflow and outflow as well as biliary drainage
  • The ability to preserve adequate future liver remnant (>20 percent in a healthy liver; >30 percent after chemotherapy)
  • Hematologic parameters defined as:
  • Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 8 g/dL
  • Blood chemistry levels defined as:
  • AST, ALT, alkaline phosphatase ≤5 times upper limit of normal (ULN)
  • Total bilirubin ≤2x the ULN. Patients with Gilbert Syndrome should have a serum bilirubin ≤ 4x ULN and a direct bilirubin ≤2x ULN to be eligible.
  • Adequate renal function as estimated by glomerular filtration rate (eGFR) >30 L/min determined based on the Cockcroft-Gault formula.
  • Anticipated life expectancy greater than 6 months.
  • Women of childbearing potential (WOCB) receiving systemic therapy should use effective contraception during treatment and for at least 9 months after the last investigational agent. Patients with partners who could become pregnant should use effective contraception during treatment and for 6 months after the last dose of investigational agent.

Who cannot join

  • • Systemic therapy with immunosuppressive agents within 7 days or use of any investigational drug within 28 days before the start of trial treatment.
  • Prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used as antineoplastic therapy for metastatic CRC.
  • Receipt of any organ transplantation, including allogeneic stem cell transplantation.
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent, such as rheumatoid arthritis, which in the opinion of the Investigator might impair the subject's tolerance or ability to participate in the trial.
  • Known severe hypersensitivity reactions to monoclonal antibodies.
  • Failure to recover from any other toxicity (other than neuropathy or immune-related toxicity) related to previous anticancer treatment to grade ≤2.
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  • Subject is pregnant or breast feeding or planning to become pregnant while enrolled in the study, up to the final (end of treatment) visit.
  • Participants unable to undergo endovascular placement of TriNav PEDD catheter due to any reason.
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months before the start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication).
  • Congestive heart failure ≥ New York Heart Association (NYHA) class 2.
  • Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before start of study drug.
  • Uncontrolled cardiac arrhythmias.
  • Poorly controlled hypertension, defined as blood pressure consistently above 150/90 mmHg despite optimal medical management.
  • Major surgical procedure or significant traumatic injury within 28 days before start of study medication. Note: If participants received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Non-healing wound, non-healing ulcer, or non-healing bone fracture.
  • Participants with evidence or history of any bleeding diathesis, irrespective of severity.
  • Any hemorrhage or bleeding event NCI CTCAE Grade ≥ 3 within 28 days prior to the start of study medication.
  • Significant acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, malabsorption, or NCI CTCAE grade ≥ 2 diarrhea of any etiology.
  • Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus (T1DM), hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • History of (non-infectious) pneumonitis that required steroids, current pneumonitis or interstitial lung disease.
  • Ongoing infection NCI-CTCAE grade >2 requiring systemic therapy.
  • Known history of positive test for HIV or known AIDS.
  • Any known positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating presence of virus, e.g. Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).
  • Pregnant or lactating women.
  • Previous treatment with live vaccine within 30 days of planned start of study drugs (seasonal flu vaccines that do not contain a live virus are permitted).
  • Known history of allergy or hypersensitivity to study drug components.
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with the participation for the full duration of the trial.
  • Any condition that would prohibit the understanding or rendering of informed consent.
  • Any medical condition that in the opinion of the investigator would interfere with the patient's safety or compliance while on trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Micaela Wigfall Maxwell contact

833-223-4732

MWigfallMaxw@northwell.edu

United States1 site, 1 recruiting

  • RJ Zuckerberg

    Lake Success, New York, 11042

    Micaela Wigfall Maxwell, 516-465-1910, MWigfallMaxw@northwell.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
Nelitolimod

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NelitolimodDrug

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the feasibility of neoadjuvant treatment with Nelitolimod delivered via PEDD in CRLM followed by surgical resection.

    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.

    Measured: 24 months

Secondary outcomes (1)

  1. To assess the safety of Nelitolimod delivered via PEDD in CRLM.

    To assess the safety of Nelitolimod delivered via PEDD in CRLM. To assess tumor regression score post-treatment with Nelitolimod and correlate with clinical outcomes, including: R0 rates, response (mRECIST), and DFS in resectable CRLM. AEs (graded by NCI CTCAE v5.0) attributed to the experimental drugs that prevent patients from getting the pre- planned surgery will be recorded, in addition to 30- day surgical complications rates. Tumor regression scores will be assessed post- treatment with Nelitolimod. The scores are based on a semiquantitative assessment of the ratio of viable tumor to fibrotic tissue. The scores range from 0 to 4, with 0 indicating no viable cancer cells and 4 indicating total regression. Tumor regression scores, response rate, and DFS are standard clinical parameters used to assess efficacy of a novel agent.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start17 Nov 2025
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07172282
Sponsor's protocol ID
25-0340
Status last verified
Mar 2026
First submitted
3 Sep 2025
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Nelitolimod in people with Colorectal Cancer Metastatic, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Micaela Wigfall Maxwell (833-223-4732, MWigfallMaxw@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the feasibility of neoadjuvant treatment with Nelitolimod delivered via PEDD in CRLM followed by surgical resection. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07172282.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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