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

Sponsor
Immunophotonics, Inc.
Study ID
NCT07321847
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 1.0% IP-001 for Injection, a 10 mg/mL solution of IP-001 in water — DRUG
    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.
  • 1.0% IP-001 for Injection, a 1 mg/mL solution of IP-001 in water. — DRUG
    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.
  • Microwave (thermal) tumor ablation — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Jan 7, 2026
Start date
May 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2033
Completion
Dec 31, 2033

Study Design

Enrollment
717 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: SOC CRLM ablation + 10 mg/mL IP-001 (IMP)
    SOC CRLM ablation: Standard of care microwave ablation is a procedure where a doctor uses imaging, such as ultrasound or CT, to guide a thin needle-like probe into a tumor. Once the probe is in place, it gives off microwave energy that heats the tumor from the inside. This heat destroys the cancer cells in that specific spot. 10 mg/ml IP-001 (IMP): IP-001 is a study medication made from a type of sugar-based molecule designed to help the immune system recognize cancer cells. The 10 mg/mL means there are 10 milligrams of the medication in each milliliter of liquid. IP-001 is injected directly into the area that was treated with ablation, where it stays local and is meant to boost the body's immune response against the cancer.
  • Experimental: Arm 2: SOC CRLM ablation + 1 mg/mL IP 001 (Diluted IMP)
    SOC CRLM ablation: Standard of care microwave ablation is a procedure where a doctor uses imaging, such as ultrasound or CT, to guide a thin needle-like probe into a tumor. Once the probe is in place, it gives off microwave energy that heats the tumor from the inside. This heat destroys the cancer cells in that specific spot. 1 mg/ml IP-001: IP-001 is a study medication made from a type of sugar-based molecule designed to help the immune system recognize cancer cells. The 1 mg/mL strength means the medication has been mixed with liquid so that there is 1 milligram of IP-001 in each milliliter of solution. This is a diluted version of the medication. IP-001 is injected directly into the area that was treated with ablation, where it stays local and is meant to boost the body's immune response against the cancer.
  • Active Comparator: Control Arm: SOC CRLM ablation alone
    SOC CRLM ablation: Standard of care microwave ablation is a procedure where a doctor uses imaging, such as ultrasound or CT, to guide a thin needle-like probe into a tumor. Once the probe is in place, it gives off microwave energy that heats the tumor from the inside. This heat destroys the cancer cells in that specific spot.

Primary Outcome Measure

To compare the efficacy of IP-001 following standard-of-care (SOC) complete hepatic tumor ablation vs SOC complete hepatic tumor ablation alone in prolonging progression-free survival [ Time Frame: From date of randomization to first documented progression (extrahepatic, or intrahepatic that could not be treated with curative-intent locoregional therapy) or death from any cause, whichever comes first, assessed up to 5 years. ]

Central Contacts

  • Kelly E Porterfield

Find similar trials

Nationwide
Colorectal cancer trialsOncology trialsGI oncology trials

Related Studies