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

INJECTABL-II: Dose Finding, Efficacy and Immunological Response of a Novel Immuno-Adjuvant (IP-001) Following Microwave Ablation or Irreversible Electroporation for Colorectal Liver Metastases.

Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM (NCT06630624) is a Phase 1 / Phase 2 interventional studying Colorectal Cancer and Liver Metastases, sponsored by M.R. Meijerink. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Colorectal Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Colorectal Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

All phases: Who May Qualify: - 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 expected to live 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 willing to sign a consent form. Who Should NOT Join This Trial: - Compromised liver function defined as warning signs of portal hypertension, INR \&gt; 1,5 without use of anticoagulants, bilirubin \&gt; x 1.5 Upper limit of normal range (ULN) ASAT \&gt;5.0 x ULN, ALAT \&gt;5.0 x ULN. - Compromised kidney function defined as eGFR \&lt;45 ml/min (using the Cockcroft Gault formula); - Active autoimmune conditions (where your immune system attacks your own body) requiring disease-modifying therapy at the time of screening or during the study period: i.e. \&gt; 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 (\&gt; grade 2 NCI-CTC version 3.0); requiring antibiotics; - Pregnant or breast-feeding subjects; 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

All phases: Inclusion Criteria: * 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. Exclusion Criteria: * Compromised liver function defined as warning signs of portal hypertension, INR \&gt; 1,5 without use of anticoagulants, bilirubin \&gt; x 1.5 Upper limit of normal range (ULN) ASAT \&gt;5.0 x ULN, ALAT \&gt;5.0 x ULN. * Compromised kidney function defined as eGFR \&lt;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. \&gt; 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 (\&gt; grade 2 NCI-CTC version 3.0); requiring antibiotics; * Pregnant or breast-feeding subjects; 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 standard of care systemic treatment for CRLM as used by the medical oncologists at Amsterdam UMC has been listed in Table 1. Patients can also be included if systemic treatment has to be terminated due to toxicity or when patients refuse (further) systemic treatment, or when patients are in a therapy break from systemic therapy as patients can continue with further systemic treatment one month after the study treatment; * 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 metastases should be performed; Exclusion Criteria: * 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 systems; * 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 treatment has to be terminated due to toxicity or when patients refuse (further) systemic treatment.; Exclusion Criteria: * 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;

Treatments Being Tested

DRUG

IP-001

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Amsterdam UMC - location VUmc

Amsterdam, North Holland, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06630624), the sponsor (M.R. Meijerink), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06630624 clinical trial studying?

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… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06630624?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06630624?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06630624. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06630624. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.