In short
SIL204 is an investigational substance being studied for the treatment of non-resectable locally advanced pancreatic cancer (LAPC). A Phase 4 clinical trial (2025-525157-39-00) is currently authorised and plans to enroll 403 participants. The trial will evaluate SIL204 given as an intratumoral injection in combination with standard chemotherapy, focusing on patients whose tumors have specific KRAS mutations.
Key points
- SIL204 is an investigational treatment for non-resectable locally advanced pancreatic cancer.
- The authorised trial is in Phase 4 and plans to enroll 403 participants.
- SIL204 is given as an intratumoral injection at a dose of 500 mg.
- The main goal is to measure overall survival (OS) over 24 months.
- The study focuses on patients with KRAS G12D or KRAS G12V mutations.
- The trial compares SIL204 plus chemotherapy against standard chemotherapy alone.
What is SIL204?
SIL204 is an investigational substance, meaning it is still being studied in clinical trials and is not yet authorized as a medicine. In the trial records, it appears under the name SIL204-SL, which refers to the specific formulation used. The substance is being developed for use in oncology, specifically for pancreatic cancer. No marketing authorisation is mentioned in the available data, confirming its status as an experimental treatment.
How does SIL204 work?
The available trial data does not describe the mechanism of action of SIL204 at a molecular level. However, the trial focuses on patients whose tumors harbor KRAS G12D or KRAS G12V mutations. KRAS is a gene that, when mutated, can drive cancer growth. The study protocol suggests that the treatment effect of SIL204 is being evaluated specifically in this genetic subgroup, but no further details on how SIL204 acts are provided in the registry record.
Which conditions is it studied for?
- Non-resectable locally advanced pancreatic cancer (LAPC): This is a form of pancreatic cancer that has grown locally and cannot be removed by surgery, but has not yet spread to distant organs. The trial includes participants with this condition.
- Metastatic pancreatic cancer: In the first segment of the trial, participants with either metastatic pancreatic cancer or non-resectable LAPC are included. Metastatic means the cancer has spread to other parts of the body.
How is SIL204 given?
In this trial, SIL204-SL is given as an intratumoral injection, meaning it is injected directly into the tumor. The dose used in the trial is 500 milligrams. The product is administered directly into the tumor tissue.
What do the clinical trials show?
One clinical trial is currently authorised for SIL204, registered under the EU CT number 2025-525157-39-00. It is a Phase 4 interventional study, meaning it is being conducted after the substance has already been tested in earlier phase trials. The trial plans to enroll 403 participants.
The trial is divided into three segments. Segment 1 evaluates the safety and tolerability of three different doses of SIL204-SC (low, medium, high) in combination with a standard SIL204-IT dose and standard-of-care chemotherapy. Segment 2 compares two selected SIL204-SC doses against standard chemotherapy alone. Segment 3, which is the primary focus, compares the selected SIL204-SC dose plus SIL204-IT plus chemotherapy against chemotherapy alone in patients with KRAS G12D or KRAS G12V mutations.
The main outcome measure is overall survival (OS), defined as the time from randomization to death from any cause, assessed for up to 24 months. Secondary outcomes include progression-free survival (PFS), complete response (CR), partial response (PR), stable disease (SD), patient-reported outcomes, and the incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.6.0).