Actively Recruiting
Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM
Led by M.R. Meijerink · Updated on 2025-07-03
120
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
Sponsors
M
M.R. Meijerink
Lead Sponsor
I
Immunophotonics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Measurable metastatic colorectal cancer based on RECIST v1.1
- Primary tumor removed or asymptomatic at study start
- Imaging within 4 weeks before ablative procedure
- Age 18 years or older
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate bone marrow, liver, and kidney function
- Signed informed consent
- Phase 1: Progressive or stable metastatic colorectal cancer after at least one systemic treatment
- At least 2 liver metastases eligible for microwave ablation, 1-3 cm in size
- Phase 2 part 1: 1 to 3 liver metastases 3 cm or smaller eligible for microwave ablation with curative intent
- Additional resectable liver metastases up to 10 allowed
- Phase 2 part 2: Liver-only or liver-dominant metastatic colorectal cancer
- At least 2 liver metastases, with 50% eligible for ablation, max 4 treated
- At least one untreated and one treated metastasis eligible for biopsy
- Maximum size of treated metastases 3 cm
- Limited extrahepatic disease in lungs or lymph nodes, max lesion size 3 cm
- Progressive disease after standard systemic treatment or treatment stopped due to toxicity or refusal
You will not qualify if you...
- Compromised liver function (e.g., signs of portal hypertension, abnormal blood tests as defined)
- Poor kidney function (eGFR below 45 ml/min)
- Active autoimmune disease needing immunosuppressive therapy
- Substance abuse or conditions interfering with study participation
- Known allergy to shellfish, crabs, crustaceans, or trial components
- History of HIV or active Hepatitis B or C infection
- Uncontrolled infections requiring antibiotics
- Pregnant or breastfeeding women; women of childbearing potential must have a negative pregnancy test
- Allergy to contrast agents that cannot be prevented
- Unstable conditions risking safety or compliance
- Major surgery or radiotherapy within 3 weeks before ablative procedure
- Systemic therapy within 4 weeks before ablative procedure
- Side effects grade 1 or higher from prior therapies at inclusion
- Phase 2 part 1: Unfeasible or unsafe radical treatment, presence of extrahepatic metastases except one treatable lung metastasis
- Prior surgical resection or focal liver therapy for liver metastases
- Phase 2 part 2: Tumors larger than 5 cm in the liver or larger than 3 cm in lungs or lymph nodes
- Metastases in organs other than liver, lungs, or lymph nodes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC - location VUmc
Amsterdam, North Holland, Netherlands, 1118 HV
Actively Recruiting
Research Team
D
Danielle J. Vos, MD
CONTACT
M
Martijn R. Meijernk, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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