NCT06630624 Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM
| NCT ID | NCT06630624 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | M.R. Meijerink |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2029-08-01 |
Trial Parameters
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Brief Summary
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
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 \> 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
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