Actively Recruiting
INJECTABL-II: Dose Finding, Efficacy and Immune Response of IP-001 After Microwave Ablation or Electroporation for Colorectal Liver Metastases
Led by M.R. Meijerink · Updated on 2025-07-03
120
Participants Needed
1
Research Sites
104 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
Researchers are studying a new treatment approach for colorectal liver metastases (CRLM), a type of cancer spread to the liver from colorectal cancer. This phase I/II clinical trial aims to find the best dose, safety, and immune response of a novel drug called IP-001 combined with ablative therapies, microwave ablation (MWA) or irreversible electroporation (IRE). The goal is to enhance the body's immune reaction against the tumor and improve survival outcomes in patients with metastatic colorectal cancer. The study is divided into three parts across two phases. Phase 1 uses a dose-escalation method to identify the maximum tolerated dose of IP-001 injected into the tumor after MWA. Phase 2 part 1 assesses the effectiveness of IP-001 following MWA in patients treated with curative intent. Phase 2 part 2 is a randomized trial comparing IP-001 combined with either MWA or IRE. Patients receive ablation of one to four liver metastases, followed by direct injection of IP-001 into the treated tumor areas. Participants will undergo imaging and laboratory tests before and after treatment to monitor safety and treatment effects. Researchers will track progression-free survival at one year, disease control rate at 16 weeks, and other outcomes such as overall survival, pain, and quality of life for up to five years. Blood samples will be taken at multiple time points after treatment to measure drug levels. The study includes safety monitoring and quality of life questionnaires during follow-up visits.
CONDITIONS
Brief 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 resected before study or asymptomatic with in situ tumor
- Imaging within 4 weeks before ablative procedure
- Age 18 years or older
- ECOG performance status 0 or 1
- Life expectancy of at least 3 months
- Adequate bone marrow, liver, and kidney function
- Written informed consent
- Phase 1: Progressive or stable metastatic colorectal cancer after at least one systemic treatment line
- Phase 1: At least 2 colorectal liver metastases (1-3 cm) eligible for microwave ablation
- Phase 2 part 1: 1 to 3 liver metastases (up to 3 cm) eligible for microwave ablation with curative intent
- Phase 2 part 1: Additional unablatable liver metastases resectable, up to 10
- Phase 2 part 2: Liver only or liver dominant metastatic colorectal cancer
- Phase 2 part 2: At least 2 liver metastases, with 50% eligible for ablation (max 4 treated)
- Phase 2 part 2: Maximum liver metastasis size 3 cm for treatment, maximum lesion size 5 cm at inclusion
- Phase 2 part 2: Limited extrahepatic disease in lungs and lymph nodes, max lesion size 3 cm
- Phase 2 part 2: Progressive disease after standard systemic treatment
You will not qualify if you...
- Compromised liver function (portal hypertension, high INR, elevated bilirubin or liver enzymes)
- Compromised kidney function (eGFR less than 45 ml/min)
- Active autoimmune disease requiring immunosuppressive therapy
- Substance abuse or conditions interfering with study participation
- Allergic reaction to shellfish, crabs, crustaceans, or trial components
- Known HIV or active hepatitis B or C infection
- Uncontrolled infections needing antibiotics
- Pregnant or breastfeeding women; women of childbearing potential without negative pregnancy test
- Known 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
- Grade 1 or higher side effects from prior therapies at inclusion
- Phase 2 part 1: Unfeasible or unsafe radical treatment; extrahepatic metastases except one treatable lung lesion; prior liver surgery or ablation
- Phase 2 part 2: Tumor diameter 5 cm or larger; metastases in lungs or lymph nodes 3 cm or larger; metastases outside liver, lungs, or lymph nodes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of ablation and injection
Participants undergo microwave ablation (MWA) or irreversible electroporation (IRE) to treat colorectal liver metastases, followed by intra-tumoral injection of IP-001.
1 visit (in-person) for ablation and IP-001 injection
Duration - Up to 16 weeks depending on study part
Participants receive intra-tumoral injections of IP-001 following ablative treatment to induce an anti-tumor immune response.
1 to 2 visits post-treatment for dose escalation and monitoring
Duration - Up to 5 years
Participants are monitored for treatment efficacy, safety, and immune response with regular assessments up to 5 years.
Regular visits scheduled over the follow-up period
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
M
Martijn R. Meijernk, Prof.
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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