Needle-based Percutaneous Ablation of Liver Tumors.

inTumo Therapeutics, Inc.

Status: Enrolling

Conditions: Metastatic Liver Tumor; HCC - Hepatocellular Carcinoma; Liver Tumors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06689670

inTumoThera

Details and patient eligibility

About

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. 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. What medical problems do participants experience when receiving INT001?

Participants will:

Receive INT001 on day 1. Visit the clinic day 7, 30 and 90. Receive lab tests during each visit and MRI on day 30 and 90.

Enrollment: 31 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Decompensated liver function, specifically Child-Pugh C, moderate to severe ascites, coagulopathy, or severe cirrhosis.
2. Signs of liver dysfunction: AST or ALT >5 times the upper limit of normal (ULN), Serum bilirubin level >2.0 mg/dL
3. Individuals with bleeding disorders.
4. History of allergy or intolerance to contrast agents to be used during imaging for assessing treatment efficacy after INT001 application.
5. Patients with life-threatening serious extrahepatic disease.
6. 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).
7. Significant medical or psychiatric illness.
8. Pregnant or breastfeeding women or women planning to conceive within the next 6 months.
9. Patients participating in another study investigating a device, drug, or procedure that may impact the study treatment outcome.
10. Lesions that do not show contrast uptake on contrast-enhanced CT or MR angiography.
11. Lesions that are not hypervascular on angiography.
12. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

INT001 Treatment

Experimental group

Description:

Patients with liver tumors enrolled in the study will receive INT001

Treatment:

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