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Efficacy and Safety of SIL204 Combined with Standard Chemotherapy in Patients with Locally Advanced Pancreatic Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults with Locally Advanced Pancreatic Cancer that cannot be removed by surgery. The experimental treatment is a sterile solution called SIL204-SL, which contains the active ingredient sil204 and is given by injection directly into the tumor, together with standard chemotherapy.

The purpose of the trial is to find out whether adding SIL204‑SL to standard chemotherapy improves how long patients live compared with chemotherapy alone, especially in tumors that have specific genetic changes known as KRAS G12D or KRAS G12V. These genetic changes are mutations that can make the cancer grow faster.

Participants are randomly placed into one of two groups: one group receives the new drug plus chemotherapy, the other receives chemotherapy only. Treatment is given in several cycles over a period of months, and patients return for regular check‑ups that include blood tests and imaging scans such as CT to look at the tumor. Doctors also watch for any side effects and record how patients feel during the study, with follow‑up continuing for up to two years after the first treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
After enrollment you are assigned by a computer to one of the treatment groups. the assignment is random and you will either receive the experimental drug together with standard chemotherapy or standard chemotherapy alone.
Step 2
Baseline assessments
Before any treatment you undergo a series of examinations that may include blood tests, electrocardiogram (ecg) to check heart function, and imaging scans such as ct to document the size and location of the tumor.
These results create a reference point for later comparisons and help the study team confirm that you meet the eligibility criteria.
Step 3
Administration of standard of care chemotherapy
You receive the usual chemotherapy that is given to patients with locally advanced pancreatic cancer. the specific medicines and schedule are determined by the treating physician and follow established clinical practice.
Chemotherapy is typically given in cycles, for example once every two weeks, and may continue for several months unless disease progression or unacceptable side effects occur.
Step 4
Administration of sil204‑sl
In the experimental arm you also receive sil204‑sl, a sterile solution that contains 500 mg of the active substance sil204.
The drug is given by intratumoral injection, which means it is injected directly into the tumor tissue.
The timing of each injection follows the study protocol, usually coordinated with the chemotherapy cycles, and continues for the duration of the treatment phase as defined by the investigators.
Step 5
Regular safety and efficacy monitoring
Throughout the treatment period you attend scheduled visits where the study staff check for side effects (adverse events) and assess how well the therapy is working.
Monitoring includes repeat blood tests, ecg recordings, and imaging scans such as ct to measure any change in tumor size.
Any side effect is graded using a standard scale (nci ctcae v.6.0) to determine its severity.
Step 6
Follow‑up period
After the active treatment phase you enter a follow‑up period that can last up to 24 months from the date of randomization.
During follow‑up you continue to have periodic assessments to record overall survival (the length of time you remain alive) and any late side effects.
These visits may be less frequent than during the active treatment phase but still include basic health checks and imaging as needed.
Step 7
Final study assessment
At the end of the 24‑month follow‑up the study team performs a final evaluation that summarizes the outcomes of the trial for you.
The results include information on survival, tumor response, and any long‑term safety observations.

Who can join the trial?

16 criteria

You must be able to understand the study information and sign a written informed consent form.
You must be at least 18 years old.
You must have a confirmed diagnosis of pancreatic cancer that is an adenocarcinoma or a mixed type, proven by tissue or cell testing.
Your cancer must be non‑resectable locally advanced (stage 3) or metastatic with no more than five spots of spread in the liver, lung, or lining of the abdomen, and you must have only one tumor in the pancreas.
Your tumor must have a KRAS gene mutation, confirmed by a tissue biopsy or a blood (liquid) biopsy.
The tumor must be reachable with a special endoscopic needle (called EUS) in at least three spots, as judged by the doctor performing the procedure.
Scans (CT or MRI) must show that the tumor can be measured according to standard criteria (RECIST v1.1).
Your overall health must be good enough to do normal daily activities, rated as 0 or 1 on the ECOG performance scale (a scale that doctors use to describe how well a patient is doing).
Your kidneys must work well, with an estimated glomerular filtration rate (eGFR) of 45 mL/min or higher.
Your blood must have enough white cells (absolute neutrophil count ≥ 1.5 billion/L), platelets (≥ 100 billion/L), and hemoglobin (≥ 8.5 g/dL).
Your liver tests must be within limits: ALT and AST no more than three times the normal upper limit, bilirubin no more than 1.5 times normal, and albumin at least 3 g/dL.
For the first part of the study, your lactate dehydrogenase (LDH) level must be no more than 1.5 times the normal upper limit.
If you have had a biliary stent placed to keep your bile duct open, your liver tests must be getting better before you can join.
If you could become pregnant, you must have a negative urine or blood pregnancy test at screening.
If you could become pregnant, you must agree to use one highly effective birth‑control method plus a barrier method (such as a condom).
Men with partners who could become pregnant must also agree to use the same two birth‑control methods.

Who cannot join the trial?

22 criteria

Having a pancreatic cancer that can be removed by surgery, or cancer that is borderline removable, or having any cancer that is not pancreatic; doctors will check this with CT, MRI, or chest X‑ray scans.
Being infected with HIV (human immunodeficiency virus) and having a detectable amount of the virus in the blood (shown by a PCR test) or having had a serious infection caused by a weak immune system in the past year.
Being a chronic carrier of Hepatitis B without receiving treatment, or having a past Hepatitis B infection but still testing positive for the surface antigen (HBsAg), which could put you at risk for the virus becoming active again.
Having Hepatitis C and not having finished a cure‑type antiviral treatment, with a measurable amount of the virus still present.
Having diabetes that is not well‑controlled, with episodes of very high or very low blood sugar that required a hospital stay in the last six months.
Having a history of a serious blood‑clotting problem (known as coagulopathy).
Being pregnant or breast‑feeding.
Having any other disease or condition that might interfere with the study or that the doctor thinks could be unsafe for you to take part.
Having active pancreatitis, which is confirmed by any of the following: blood levels of the enzymes amylase or lipase that are three times higher than normal, pain in the upper belly that spreads to the back, or imaging (CT, MRI, or ultrasound) that shows pancreatitis.
Not planning to receive any drugs that target low‑oxygen (hypoxic) cells in the standard chemotherapy regimen.
Receiving active radiation (radiotherapy) aimed at the tumor area.
For certain parts of the study (Segments 2 and 3): also being excluded if the pancreatic cancer has spread (metastatic).
Currently taking part in, or having taken part in, another experimental drug study where the drug was given within five times the drug’s half‑life before signing the consent form.
Being unwilling or unable to follow the study rules and schedule.
Being judged by the doctor as unable to meet the study’s requirements.
Having noticeable fluid buildup in the abdomen (called ascites) beyond a very small amount.
Having received any previous treatment specifically for pancreatic cancer.
Having a type of pancreatic tumor that is not an adenocarcinoma, such as pure squamous cancer, acinar cell carcinoma, or a neuroendocrine tumor.
Having a history of another cancer, unless you have been completely free of that cancer for at least three years and are not currently receiving chemotherapy, PARP‑inhibitor drugs, or immunotherapy; small skin cancers, cancers in place (carcinoma in situ), and hormone therapy for breast or prostate cancer are allowed exceptions.
Having had major surgery (other than a diagnostic procedure) within the last four weeks and not having fully recovered.
Having serious heart problems, such as being in New York Heart Association (NYHA) Class 3 or 4, a heart attack within the past six months, an unstable irregular heartbeat (arrhythmia), or noticeable disease of the arteries that supply the limbs (peripheral arterial vascular disease).
Having an active, uncontrolled infection (bacterial, viral, or fungal) that requires treatment.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
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Ulm, Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Verified
Munich, Germany
Klinikum der Universitaet Muenchen AöR
Verified
Munich, Germany

Trial locations

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Investigated drugs

SIL204‑SL
is an experimental sterile liquid that is injected directly into the tumor. In this trial it is given together with the usual chemotherapy to see if adding it helps patients with advanced pancreatic cancer live longer and stay healthier.
SIL204‑IR
is another form of the same experimental drug. It is used as part of the combined treatment plan with chemotherapy, and the study is checking how well it works and how safe it is when added to the standard cancer medicines.
SIL204‑SC
is the experimental drug given under the skin (subcutaneously). The trial tests three different dose levels of this form, each used together with a standard dose of the drug given directly into the tumor and with chemotherapy, to find the best amount to use.
SIL204‑IT
is the experimental drug delivered directly into the tumor (intratumoral). A standard dose of this preparation is used in combination with the subcutaneous form and chemotherapy, allowing the researchers to study how the drug works when placed right at the tumor site.
Standard chemotherapy (SoC chemotherapy)
refers to the usual chemotherapy medicines that are commonly given to treat pancreatic cancer. In this study all participants receive these drugs, and the researchers compare the results of the experimental drug combinations against chemotherapy alone.

What is already known about the treatment

SIL204-SL - SIL204-SL is given as a sterile liquid that is injected directly into the tumor (intratumoral use) at a dose of 500 mg. The drug is still experimental and is being tested in a phase 2/3 clinical trial for patients with non‑resectable locally advanced pancreatic cancer. It is designed to block the activity of mutant KRAS proteins (G12D or G12V), which helps to slow down the growth of cancer cells. SIL204‑SL belongs to the class of targeted cancer therapies known as KRAS inhibitors.

Investigated diseases

Locally advanced pancreatic cancer - Locally advanced pancreatic cancer is a stage of pancreatic cancer where the tumor has grown into nearby blood vessels or organs but cannot be removed surgically. The disease typically begins with abnormal cell growth in the pancreas that forms a mass. Over time, the cancer spreads locally, invading surrounding tissues and sometimes causing blockages in the digestive tract. It may also affect the function of the pancreas, leading to digestive problems. As the tumor expands, it can cause pain in the abdomen or back and may lead to weight loss.