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Tests treatment safety and results for Colorectal Cancer
Official title Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM
ClinicalTrials.gov ID: NCT06630624
What this study is testing
What is IP-001?
IP-001 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All phases:
- 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;
You likely can't join if
- Compromised liver function defined as warning signs of portal hypertension, INR \> 1,5 without use of anticoagulants, bilirubin \> x 1.5 Upper limit...
- 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...
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the...
- Known allergic reaction to shellfish, crabs, crustaceans, or any trial components;
- Known history of HIV or active Hepatitis C or Hepatitis B infection;
See the full eligibility criteria
Who can join
- All phases:
- 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;
- Eastern Cooperative Oncology Group (ECOG) performance status of no more than 1;
- A life expectancy of at least 3 months at the time of inclusion;
- Adequate bone marrow, liver, and renal function as assessed by laboratory tests. These results should be judged by the local investigator and should be conducted within 7 days prior to definite inclusion;
- Written informed consent.
What rules you out
- 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;
- Known allergic reaction to shellfish, crabs, crustaceans, or any trial components;
- Known history of HIV or active Hepatitis C or Hepatitis B infection;
- Uncontrolled infections (\> grade 2 NCI-CTC version 3.0); requiring antibiotics;
- Pregnant or breast-feeding people; Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment;
- Known allergy to contrast agent that cannot be adequately prevented;
- Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study;
- Major surgery or radiotherapy ≤ 3 weeks (7 days for single fraction of palliative radiotherapy) prior to the on-study ablative procedure;
- Systemic therapy ≤ 4 weeks prior to the on-study ablative procedure;
- CTCAE Grade ≥1 from all side effects of prior therapies or prior procedures at the time of inclusion. Phase 1 Inclusion Criteria:
- Progressive or stable metastatic CRC on CT-scan after at least 1 lines of standard of care systemic treatment. Standard of care systemic treatment will be defined and determined by the treating oncologist. A summary of...
- At least 2 CRLM eligible for MWA with a minimum diameter of 1cm and a maximum diameter of 3cm and one (optional but not required) CRLM that will be left untreated and is eligible for biopsy;
- No limitations on intrahepatic or extrahepatic disease; Exclusion Criteria: \- No additional exclusion criteria. Phase 2 part 1: Inclusion Criteria:
- At least one CRLM and a maximum of three CRLM size ≤ 3 cm eligible for MWA with curative intent;
- Additional unablatable CRLM should be resectable with a maximum of 10 additional CRLM;
- Resectability and ablatability should be re-confirmed intra-operatively by US in case of combined/staged resection and ablation. Intra-operatively also full exploration for hepatic, peritoneal and regional lymph node...
- Radical treatment unfeasible or unsafe (e.g. insufficient FLR);
- The presence of extrahepatic nodal or non-nodal metastases. One locally treatable lung metastasis is allowed;
- Any surgical resection or focal ablative liver therapy for CRLM prior to inclusion; Phase 2 part 2: Inclusion Criteria:
- Liver only or liver dominant measurable metastatic CRC based on RECIST v1.1;
- Liver dominant metastatic disease is defined as the hepatic tumorload (number and estimated volume) exceeding the extrahepatic tumorload, with a maximum of 5 unequivocal extrahepatic metastases in ≤2 different organ...
- At least 2 CRLM, of which at least one is eligible for the study treatment (RFA, MWA and IRE);
- At least 50% (number and estimated volume) of the CRLM should be eligible for ablation. A maximum of 4 CRLM can be assigned for the study treatment. One CRLM has to be left untreated;
- At least one untreated CRLM and one 'to-be-treated' CRLM should be eligible for biopsy;
- Maximum size of CRLM for study treatment is 3cm;
- Any CRLM with a maximum lesion size of 5cm at time of inclusion;
- Limited extrahepatic disease, restricted to the lungs and lymph nodes, with a maximum lesion size of 3cm at time of inclusion. See below for additional information regarding pulmonary nodules;
- Progressive disease on CT-scan after standard of care systemic treatment. Standard of care systemic treatment will be defined and determined by the treating oncologist. Patients can also be included if systemic...
- Tumor diameter of ≥ 5 cm of any hepatic lesion at the time of inclusion. If lesion size exceeds 5 cm at start of the procedure, the patient will not be excluded;
- Metastases in the lungs or lymph nodes ≥ 3 cm. If lesion size exceeds 3 cm at start of the procedure, the patient will not be excluded;
- Metastases in any other organ than the liver, lungs of lymph nodes;
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.