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.
Patients ≥ 18 y of age at the time of signing the Informed Consent Form in accordance with local regulatory and/or national laws and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) regulations (consent must be received before any study-specific activity is performed).
No more than 5 CRLM (≤ 3 cm for largest diameter)
An indication to receive percutaneous or laparoscopic SOC complete CRLM ablation with the intent of leaving no detectable liver disease
Tumors amenable to ablation treatment in a single session
Patients from vulnerable populations (incapacitated or unconscious individuals, persons deprived of liberty).
Patients with a known allergic reaction or hypersensitivity to shellfish, crabs, crustaceans, or any components used in trial treatment.
Patients with any prior treatment with IP-001 for Injection in a different clinical trial.
Patients who underwent any surgical liver resection, hepatic ablation or other hepatic locoregional therapy for CRLM within 3 months before Treatment Day 1; patients who received any other medical procedure, SACT, or treatment with any other investigational anticancer agents within 14 days before Treatment Day 1, or patients who at study enrollment have plans to receive SACT or locoregional therapies/procedures prior to intrahepatic or extrahepatic progression.
Parallel
1.0% IP-001 for Injection, a 10 mg/mL solution of IP-001 in water
DrugIP-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.
DrugIP-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/SurgeryMicrowave 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.
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
Progression-free survival (PFS) is defined as the time from randomization to first occurrence of objectively documented (1) extrahepatic progression or (2) intrahepatic progression (that could not be treated with curative-intent locoregional therapy) per RECIST v1.1, assessed by a Blinded Independent Central Review (BICR), or (3) death from any cause, whichever occurs first.
To compare disease control of IP-001 following SOC complete hepatic tumor ablation vs SOC complete hepatic tumor ablation alone
* Extrahepatic PFS (ePFS) is defined as the time from randomization to first documented extrahepatic progression per RECIST v1.1 assessed by BICR, or death from any cause, whichever occurs first. * Intrahepatic PFS (iPFS) is defined as the time from randomization to first documented intrahepatic progression per RECIST v1.1 assessed by BICR, or death from any cause, whichever occurs first. * PFS is defined as the time from randomization to first documented (1) extrahepatic progression or (2) intrahepatic progression that could not be treated with curative-intent locoregional therapy per RECIST v1.1, assessed by the Investigator, or (3) death from any cause, whichever occurs first. * ePFS is defined as the time from randomization to first occurrence of objectively documented extrahepatic progression per RECIST v1.1, assessed by the Investigator, or death from any cause, whichever occurs first.
To compare survival outcomes of IP-001 following SOC complete hepatic tumor ablation vs SOC complete hepatic tumor ablation alone
Overall survival (OS) is defined as the time from randomization to death from any cause.
To compare time to progression events between IP-001 following SOC complete hepatic tumor ablation and SOC complete hepatic tumor ablation alone
* Time to Progression (TTP) is defined as the time from randomization to objectively documented intrahepatic or extrahepatic progression, per RECIST v1.1, assessed by BICR. * TTP is defined as the time from randomization to objectively documented intrahepatic or extrahepatic progression, per RECIST v1.1, assessed by the Investigator. * Time to Loss of Hepatic Control (TLHC) is defined as the time from randomization to objectively documented intrahepatic progression that cannot be treated with curative intent by locoregional therapy, assessed by the Investigator.
To compare safety and tolerability (via incidence of treatment-emergent adverse events) of IP-001 following SOC complete hepatic tumor ablation and SOC complete hepatic tumor ablation alone.
Incidence and severity of AEs, serious adverse events (SAEs), adverse events of special interest (AESIs), deaths, and laboratory abnormalities.
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