INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases

NCT07172282 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 25-0340
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (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.

  24 months

Secondary Outcomes (1)

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

  36 months

Interventions

Nelitolimod DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

RJ Zuckerberg

Lake Success, New York, 11042, United States

RECRUITING

Central Study Contacts

Micaela Wigfall Maxwell

CONTACT

833-223-4732; MWigfallMaxw@northwell.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 15, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)