Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis

NCT07193862 | Recruiting Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 25-0004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors. This is a prospective, phase 1 safety study of percutaneous placement and surgical retrieval of a microdevice in patients with liver metastasis from colorectal cancer. The device will be implanted percutaneously 3-5 days prior to scheduled resection of colorectal liver metastasis (CLM) and then removed en bloc with the tumor. Patients will be monitored to ensure that the device's placement and retrieval does not result in increased complication rates within 14 days of surgery. To assess feasibility, the tissue surrounding the microdevice will be analyzed to assess the diffusion of the drugs from the device into the tissue and whether the therapeutic effect of diffusing chemotherapy +/- immune-modulating drugs has an impact on the surrounding tissue.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs) associated with Microdevice placement and retrieval

  To evaluate the safety of microdevice placement and retrieval based on assessment of adverse events. AEs will be defined using Common Terminology Criteria for AEs (CTCAE) v5.0 Any device resulting in either of the following will be considered a failure from a safety standpoint: any listed SAE two or more grade 3-4 AEs directly associated with the device or its placement Significant delay in the standard hepatic resection of more than 14 days due to device-related complications Safety will be evaluated on a per-patient level, where an event is defined as any "failure" observed among all devices. This is a phase 1 pilot safety trial that must only demonstrate the ability to perform this procedure without undue risk

  12 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Subjects will have the device placed loaded with chemotherapeutic agents.

Combination Product: Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373

Interventions

Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373 COMBINATION_PRODUCT

Patients with diagnosed liver metastasis from a colorectal primary deemed resectable. The study intervention will be limited to the percutaneous placement of up to 2 IMDs per lesion with a maximum of 4 devices total, with the subsequent en bloc resection of the tumor plus IMD within 3 (+2) days after placement. The microdevices will remain in the tumor for a minimum of a 2-day incubation period, although ideally for 3 days. The IMD is a small cylindrical device approximately 750 um in diameter and 5 mm in length (Figure 2), housing up to 21 reservoirs. It is made of PEEK, biocompatible material used in other implantable constructs, including joint replacements. 11-13 Drugs are solubilized with poly-ethylene glycol (PEG) and loaded into the individual reservoirs. The drug diffusion has been mapped extensively to ensure that the weight of PEG is selected such that drug diffusion is limited and will not mix or interfere with another drug.

Single Arm

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed colorectal cancer with suspicion of liver metastasis on imaging Liver tumor ≥2 cm on preoperative imaging via computed tomography (CT) or magnetic resonance imaging (MRI) Planned hepatectomy as part of standardized treatment plan, irrespective of study enrollment ≥18 years of age
• Normal organ and marrow function, defined as follows:
• Leukocytes ≥3,000/mcL
• Absolute neutrophil count ≥1500/mcL
• Platelets ≥ 100,000/mcL
• PT≤ 14, PTT≤ 38, INR ≤ 1.
• Creatinine within normal institutional limits OR clearance ≥60mL/min/1.73m2 Feasibility of microdevice implantation based on clinical history as well as extent and anatomical location of the CLM tumor as evaluated by the operating surgical oncologist and interventional radiologist on baseline imaging The effects of the microdevice on a developing human fetus are unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of childbearing age must agree to have a negative serum pregnancy test within 48 hours of their operation Ability to understand and willingness to sign informed consent for both the surgical resection and the proposed research study prior to any procedures
• Males and females of childbearing potential must agree to use effective contraception starting before the first day of treatment and continuing for at least 3 months (men) or 6 months (women) after implantation of the microdevice. Additionally, due to the unknown but potential risks of nursing infants secondary to the treatment of the mother with the chemotherapeutic agents of the study, mothers must agree to discontinue breastfeeding for a total of 14 days after the insertion of the microdevice.

You may not qualify if:

• Tumor location not amenable to device placement Pregnancy at the time of enrollment or operation due to the known teratogenicity of the medications involved.
• Prior or concurrent second primary malignancy whose natural history or treatment has the potential to interfere with the safety or primary endpoint efficacy assessment of the CLM Extra-hepatic disease or unresectable liver metastasis on baseline imaging

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (2)

RJ Zuckerberg

Lake Success, New York, 11042, United States

RECRUITING

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

MeSH Terms

Interventions

Doxorubicin; Folfox protocol; balstilimab; Bevacizumab; folfirinox

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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 26, 2025
• Study Start: December 10, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)