Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IP-001 · 1 trial · 3 indications
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...
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IP-001 is an investigational small molecule being studied for the treatment of colorectal cancer, specifically in patients with liver metastases. It is administered following microwave ablation (MWA) or irreversible electroporation (IRE) procedures to evaluate its dose, efficacy, and immunological response in this setting.
IP-001 is being developed by AngioDynamics, Inc., a company traded on NASDAQ under the ticker symbol ANGO. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with colorectal cancer liver metastases.
IP-001 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in a clinical trial setting.
IP-001 is being studied in a single Phase 1 trial with the identifier NCT06630624. This trial is titled 'Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM' and is currently recruiting participants in the Netherlands.
The specific molecular target of IP-001 has not been disclosed. The drug is being evaluated for its immunological response when used after tumor ablation procedures, suggesting it may modulate the immune system, but its exact mechanism of action is not publicly detailed.