Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06630624 | Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM | PHASE1 | RECRUITING | 120 | — | — | Jul 10, 2024 | Aug 1, 2031 | Jul 3, 2025 | 1 | Netherlands |
The highest dose of IP-001 that does not cause unacceptable side effects defined as the dose level below the dose level that caused 2 or more Dose Limiting Toxicites (DLTs).
Overall DPFS is defined as the time from inclusion to the time of disease progression (according to the RECIST 1.1 guideline) or death (events). Death related to other causes is considered a failure event for DPFS.
DCR is calculated as the percentage of patients experiencing either iSD (Stable Disease), iPR (Partial Response) or iCR (Complete Response) as best response in target lesions at 16 weeks after treatment according to iRECIST.
| Arm | Type | Description |
|---|---|---|
| Phase 1 Dose esclatation of IP-001 | EXPERIMENTAL | Intra-tumoral injection of IP-001 following MWA of two pre-defined colorectal liver metastases (CRLM). Patients will receive sequentially higher doses of the IP-001, always divided equally over the two CRLM, regardless of size. Starting dose will be 8 mL and the dose-escalating steps will be 4 mL up to a total of 16 mL per patient. |
| Phase 2 Part 1 MWA + IP-001 | EXPERIMENTAL | One to three colorectal liver metastases (CRLM) will be treated with MWA followed by intra-tumoral injection of IP-001. |
| Phase 2 part 2 MWA + IP-001 | EXPERIMENTAL | One to four colorectal liver metastases (CRLM) will be treated with MWA followed by intra-tumoral injection of IP-001. |
| Phase 2 part 2 IRE + IP-001 | EXPERIMENTAL | One to four colorectal liver metastases (CRLM) will be treated with IRE followed by intra-tumoral injection of IP-001. |
| Name | Type | Description |
|---|---|---|
| IP-001 | DRUG | Intra-tumoral injection of IP-001 following ablation (MWA or IRE). |
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 yea...