In short
Ieramilimab, also known as LAG525, is an investigational drug being studied for the treatment of various types of advanced cancer. This article provides an overview of the clinical trials involving Ieramilimab, its potential benefits, and what patients should know about participating in these studies.
At a glance
- Drug Name
- Ieramilimab (LAG525)
- Drug Type
- Monoclonal antibody
- Target Condition
- Different types of advanced cancer
- Administration Method
- Intravenous use
- Maximum Daily Dose
- 800 mg
- Maximum Total Dose
- 106.4 g
- Maximum Treatment Period
- 533 days
- Primary Endpoint
- Frequency and nature of adverse events and serious adverse events
- Secondary Endpoint
- Number of subjects receiving treatment and duration of exposure
What is IERAMILIMAB?
IERAMILIMAB, also known by its product code LAG525, is an investigational drug being developed by Novartis Pharma AG for the treatment of various types of advanced cancer. It is a type of medication called a monoclonal antibody, which is a laboratory-made protein that mimics the immune system's ability to fight off harmful antigens such as cancer cells.
IERAMILIMAB is also referred to by other names, including:
- NVP-LAG525
- Anti-LAG-3 monoclonal antibody LAG525
- LAG525
These alternative names may be used in scientific literature or by healthcare professionals when discussing this treatment.
Medical Conditions Treated
IERAMILIMAB is being studied for the treatment of different types of advanced cancer. Advanced cancer generally refers to cancer that has spread from its original site to other parts of the body or has grown extensively at its original site. The drug is not limited to one specific type of cancer, which suggests it may have potential applications across various cancer types.
How IERAMILIMAB Works
IERAMILIMAB is an anti-LAG-3 monoclonal antibody. LAG-3 (Lymphocyte-activation gene 3) is a protein found on the surface of certain immune cells. In some cancers, LAG-3 can act as a "brake" on the immune system, preventing it from effectively fighting cancer cells. By targeting and blocking LAG-3, IERAMILIMAB aims to release this brake, potentially allowing the immune system to more effectively recognize and attack cancer cells.
How IERAMILIMAB is Administered
IERAMILIMAB is administered as a concentrate for solution for infusion. This means that the drug is given intravenously (directly into a vein) after being diluted. The infusion is typically done in a hospital or clinic setting under the supervision of healthcare professionals.
The maximum daily dose of IERAMILIMAB is 800 mg, and the maximum total dose over the course of treatment is 106.4 g. The treatment period can last up to 533 days, which is approximately 1.5 years. However, the exact dosing and duration of treatment may vary depending on individual patient factors and how well the treatment is tolerated.
Current Clinical Trials
IERAMILIMAB is currently being studied in clinical trials to evaluate its safety and effectiveness. One ongoing study is a rollover trial, which allows patients who have participated in previous Novartis-sponsored studies of spartalizumab (another cancer drug) to continue receiving treatment. The main objectives of this study are:
- To collect safety and tolerability data for spartalizumab alone or in combination with other study treatments, including IERAMILIMAB
- To allow subjects enrolled in spartalizumab Novartis-sponsored studies continued access to study treatment
Eligibility for Treatment
To be eligible for treatment with IERAMILIMAB in the current clinical trial, patients must meet certain criteria:
- Be currently enrolled in a pre-defined Novartis-sponsored study and receiving spartalizumab alone or in combination with other study treatments
- Be deriving clinical benefit from the study treatment, as determined by the investigator
- Have demonstrated compliance with the parent protocol requirements
- Be willing and able to comply with scheduled visits and treatment plans
- Provide signed informed consent
Patients who have been permanently discontinued from spartalizumab in the parent protocol for any reason other than enrollment in the specific study (CPDR001X2X01B) are not eligible.
Safety and Side Effects
As IERAMILIMAB is still in clinical trials, its full safety profile is not yet established. The primary endpoint of the current study is to assess the frequency and nature of adverse events (AEs) and serious adverse events (SAEs), as well as instances of dose interruptions and reductions.
It's important to note that all medications can have side effects, and the potential risks and benefits should be discussed with a healthcare provider. During clinical trials, patients are closely monitored for any adverse reactions to ensure their safety.