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.