Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Measurable metastatic CRC based on RECIST v1.1;

The primary tumor has been resected before study inclusion or the patient is asymptomatic with respect to the in situ primary tumor;

Last imaging ≤ 4 weeks prior to the on-study ablative procedure;

Age ≥ 18 years;

Disqualifiers

Compromised liver function defined as warning signs of portal hypertension, INR > 1,5 without use of anticoagulants, bilirubin > x 1.5 Upper limit of normal range (ULN) ASAT >5.0 x ULN, ALAT >5.0 x ULN.

Compromised kidney function defined as eGFR <45 ml/min (using the Cockcroft Gault formula);

Active autoimmune disease requiring disease-modifying therapy at the time of screening or during the study period: i.e. > 10 mg prednisolone per day or other immunosuppressive therapy (e.g. methotrexate);

Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results;

Trial design

Treatments tested in this trial

  • IP-001

Treatment groups

120 Participants
are divided into 4 treatment groups

Locations

1
Amsterdam UMC - location VUmc1118 HV, AmsterdamNorth Holland, Netherlands

Sponsors and collaborators

M.R. Meijerink

Lead sponsor

Amsterdam UMC, location VUmc

Sponsor institution

Immunophotonics, Inc.

Collaborator

Angiodynamics, Inc.

Collaborator

Source ClinicalTrials.gov