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

NCT06630624 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

IP-001

Intra-tumoral injection of IP-001 following ablation (MWA or IRE).

Sponsors & Collaborators

  • Immunophotonics, Inc.

    collaborator INDUSTRY

  • Angiodynamics, Inc.

    collaborator INDUSTRY

  • M.R. Meijerink

    lead OTHER

Principal Investigators

  • Martijn R. Meijerink, Prof. · Amsterdam UMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2029-08-01
Completion
2031-08-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT06630624 on ClinicalTrials.gov