NCT06689670

Brief Summary

The goal of this clinical trial is to learn if INT001 can ablate liver tumors in adults in an outpatient setting. It will also help us learn about the safety of INT001. The main questions it aims to answer are:

  1. 1.Using a needle under image guidance, the liver tumor is accessed and INT001 is injected. Upon injection into tumor, does INT001 ablate/kill the tumor entirely?
  2. 2.What medical problems do participants experience when receiving INT001?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Oct 2024Dec 2027

Study Start

First participant enrolled

October 28, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

November 6, 2024

Last Update Submit

January 15, 2026

Conditions

Liver TumorsHCC - Hepatocellular CarcinomaMetastatic Liver Tumor

Keywords

livertumorablationneedleout-patient

Outcome Measures

Primary Outcomes (2)

  • Ablation

    Ablation of the tumor will be assessed using imaging criteria such as RECIST.

    MRI will be performed the day of the intervention, at 30 days and at 90 days.

  • Adverse events

    Procedure-Related and Post-Procedure Complications Complications related to the procedure and the postoperative period

    From day 1 to day 90

Secondary Outcomes (1)

  • Biomarkers

    Day 30 and Day 90

Study Arms (1)

INT001 Treatment

EXPERIMENTAL

Patients with liver tumors enrolled in the study will receive INT001

Device: Needle based delivery of INT001 into liver tumors under real-time image guidance

Interventions

Needle based delivery of INT001 into liver tumors under real-time image guidanceDEVICE

Using ultrasound or CT imaging, the liver tumor is located. Under local anesthesia or, if necessary, intravenous sedation, the needle is inserted through the skin and the needle tip is brought to the center of the liver tumor using image guidance. 1-2 ml of the INT-001 is injected. The needle is removed and a bandaid is applied to the skin entry site. Right after, or as soon as MRI becomes available, MRI is performed to show that the entire tumor has been treated.

Also known as: Percutaneous tumor ablation
INT001 Treatment

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of primary or secondary liver cancer.
  • ECOG Performance Status score of 0 - 2
  • Age ≥18 years, \<100 years
  • Life expectancy of ≥3 months
  • Patient is unsuitable for surgical resection or transplantation
  • Ability of the patient to understand and sign the Informed Consent Form describing the study's nature
  • Volunteer's willingness and ability to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits

You may not qualify if:

  • Decompensated liver function, specifically Child-Pugh C, moderate to severe ascites, coagulopathy, or severe cirrhosis.
  • Signs of liver dysfunction: AST or ALT \>5 times the upper limit of normal (ULN), Serum bilirubin level \>2.0 mg/dL
  • Individuals with bleeding disorders.
  • History of allergy or intolerance to contrast agents to be used during imaging for assessing treatment efficacy after INT001 application.
  • Patients with life-threatening serious extrahepatic disease.
  • Patients with concurrent conditions that, in the investigator's opinion, would prevent clinical benefit from the study procedure or could compromise patient safety or study objectives (including but not limited to ongoing infection, renal dysfunction, or morbidity).
  • Significant medical or psychiatric illness.
  • Pregnant or breastfeeding women or women planning to conceive within the next 6 months.
  • Patients participating in another study investigating a device, drug, or procedure that may impact the study treatment outcome.
  • Lesions that do not show contrast uptake on contrast-enhanced CT or MR angiography.
  • Lesions that are not hypervascular on angiography.
  • Patients who do not have CT or MR imaging available at the screening visit or are unwilling or unable to undergo MRI for various reasons during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koc University Hospital

Topkapı, Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Keum H, Albadawi H, Zhang Z, Graf E, Santos PRD, Gunduz S, Oklu R. Bioengineered Ionic Liquid for Catheter-Directed Tissue Ablation, Drug Delivery, and Embolization. Adv Mater. 2024 Jun;36(23):e2309412. doi: 10.1002/adma.202309412. Epub 2024 Feb 16.

    PMID: 38305472RESULT

  • Cevik E, Albadawi H, Zhang Z, Demirlenk Y, Atar D, Keum C, Kim J, Graf E, Gunduz S, Rehman S, Oklu R. Catheter-Directed Ionic Liquid Embolic Agent for Rapid Portal Vein Embolization, Segmentectomy, and Bile Duct Ablation. Adv Mater. 2024 Jul;36(29):e2402570. doi: 10.1002/adma.202402570. Epub 2024 May 7.

    PMID: 38678378RESULT

  • Demirlenk YM, Albadawi H, Zhang Z, Atar D, Cevik E, Keum H, Kim J, Rehman S, Gunduz S, Graf E, Mayer JL, Dos Santos PR, Oklu R. Prostate tissue ablation and drug delivery by an image-guided injectable ionic liquid in ex vivo and in vivo models. Sci Transl Med. 2024 Jul 3;16(754):eadn7982. doi: 10.1126/scitranslmed.adn7982. Epub 2024 Jul 3.

    PMID: 38959326RESULT

  • Albadawi H, Zhang Z, Keum H, Cevik E, Nagalo BM, Gunduz S, Kita H, Oklu R. Percutaneous Delivery of Oncogel for Targeted Liver Tumor Ablation and Controlled Release of Therapeutics. Adv Mater. 2024 Nov;36(45):e2406080. doi: 10.1002/adma.202406080. Epub 2024 Aug 15.

    PMID: 39148179RESULT

MeSH Terms

Conditions

Carcinoma, HepatocellularNeoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Fatih Selcukbiricik, MD

    Koc University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahmi Oklu, MD, PhD

CONTACT

+90 850-250-8250roklu@intumotherapeutics.com

Erhan Bayburtluoglu, BS

CONTACT

+90 850-250-8250ctu@kuh.ku.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, Single-Arm, Open-label, Single-Center Clinical Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 14, 2024

Study Start

October 28, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

TU(1)