Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM

The primary objectives of this phase I/II, prospective clinical trial, are to assess the optimal dose, efficacy, safety and immunological effect of ablation and intra-tumoral injection of a novel immuno-adjuvant (IP-001) for colorectal liver metastases (CRLM). The study consists of three parts, devided into two phases. Phase 1 is a dose-escalation study according to a classic '3+3' design, to identify the dose level at which IP-001 exhibits an acceptable level of toxicity following microwave ablation (MWA) of CRLM in refractory metastatic colorectal cancer (CRC) patients. Phase 2, part 1 and part 2 are performed simultaneously. In phase 2 part 1, a single arm study assesses the efficacy of IP-001 following MWA for CRLM for curative intent. In phase 2 part 2, a randomized, two-armed study assesses the efficacy and immunomodulation of IP-001 following two ablative modalities: arm A (MWA) and arm C (irreversible electroporation (IRE)) for CRLM in refractory metastatic CRC patients.

NCT Number	NCT06630624
Lead Sponsor	M.R. Meijerink Collaborators: Immunophotonics, Inc., Angiodynamics, Inc.
Conditions	Colorectal Cancer, Liver Metastases, Liver Metastasis Colon Cancer
Enrollment	120 participants
Start Date	2024-07-10
Primary Completion	2029-08-01 (estimated)
Study Completion	2031-08-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-03