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Injection of IP-001 Into Thermally Ablated Hepatic Tumors in Patients With Colorectal Liver Metastases

NCT07321847 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 717

Last updated 2026-01-07

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if a new injectable drug (IP-001), administered after standard liver tumor ablation, can help prevent cancer from returning in people (males/females, ≥18 years old) with colorectal cancer that has spread only to the liver. The study will determine if injecting IP-001 into a liver tumor(s) after ablation will reduce the risk of cancer coming back in the liver and from spreading elsewhere in the body, will stimulate the immune system, will have any side effects, and will help improve a patient's response to other cancer therapies.

Researchers will compare a standard of care liver ablation alone (microwave ablation \[MWA\], a technique that destroys tumors using heat), with MWA plus a high-dose IP-001 or MWA with a low-dose IP-001. During the treatment procedures, the doctor first performs the standard microwave ablation to destroy the tumor. Then, in the experimental-drug arms, IP-001 is injected in and around the treated tumor area to activate the immune system locally so that the body is more likely to find and eliminate any remaining cancer cells.

Conditions

  • Colorectal Cancer (CRC)
  • Colon Cancer Liver Metastases
  • Rectal Cancer
  • Rectal Cancer With Liver Metastases
  • Colorectal Liver Metastasis (CRLM)

Interventions

DRUG

1.0% IP-001 for Injection, a 10 mg/mL solution of IP-001 in water

IP-001 is a novel, non-cytotoxic, immunostimulatory glycan polymer administered as a single intratumoral injection into the ablation zone immediately following standard of care image-guided microwave thermal ablation of a target tumor lesion.

DRUG

1.0% IP-001 for Injection, a 1 mg/mL solution of IP-001 in water.

IP-001 is a novel, non-cytotoxic, immunostimulatory glycan polymer administered as a single intratumoral injection into the ablation zone immediately following standard of care image-guided microwave thermal ablation of a target tumor lesion.

PROCEDURE

Microwave (thermal) tumor ablation

Microwave ablation is a common medical procedure where doctors use imaging (like ultrasound or CT) to guide a thin probe into a tumor. The probe gives off microwave energy that heats up the tumor from the inside, causing the cancer cells in that spot to die. Unlike treatments such as chemotherapy or immunotherapy, which travel through the whole body, microwave ablation works only on the specific area being treated. It does not involve any drugs or medicines circulating in the bloodstream. It is a local treatment that targets just the tumor.

Sponsors & Collaborators

  • Immunophotonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Diane M Beatty, PhD · Immunophotonics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2033-12-31
Completion
2033-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07321847 on ClinicalTrials.gov