OncoMatch/Clinical Trials/NCT06630624
Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM
Is NCT06630624 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies IP-001 for colorectal cancer.
Treatment: IP-001 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — standard of care
Progressive or stable metastatic CRC on CT-scan after at least 1 lines of standard of care systemic treatment
Cannot have received: surgical resection or focal ablative liver therapy for CRLM
Any surgical resection or focal ablative liver therapy for CRLM prior to inclusion (Phase 2 part 1 exclusion)
Cannot have received: systemic therapy
Systemic therapy ≤ 4 weeks prior to the on-study ablative procedure
Cannot have received: radiotherapy
Exception: 7 days for single fraction of palliative radiotherapy
Major surgery or radiotherapy ≤ 3 weeks (7 days for single fraction of palliative radiotherapy) prior to the on-study ablative procedure
Lab requirements
Blood counts
Adequate bone marrow function as assessed by laboratory tests.
Kidney function
Adequate renal function as assessed by laboratory tests. Compromised kidney function defined as eGFR <45 ml/min (using the Cockcroft Gault formula).
Liver function
Adequate liver function as assessed by laboratory tests. Compromised liver function defined as warning signs of portal hypertension, INR > 1.5 without use of anticoagulants, bilirubin > 1.5 x ULN, ASAT >5.0 x ULN, ALAT >5.0 x ULN.
Adequate bone marrow, liver, and renal function as assessed by laboratory tests. Compromised liver function defined as warning signs of portal hypertension, INR > 1.5 without use of anticoagulants, bilirubin > 1.5 x 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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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