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Ieramilimab

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.

Table of Contents

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[1]. 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[1].

Medical Conditions Treated

IERAMILIMAB is being studied for the treatment of different types of advanced cancer[1]. 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[1]. 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[1]. 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[1]. The treatment period can last up to 533 days, which is approximately 1.5 years[1]. 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[1]. The main objectives of this study are:

  1. To collect safety and tolerability data for spartalizumab alone or in combination with other study treatments, including IERAMILIMAB
  2. 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[1]:

  • 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[1].

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[1].

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.

Aspect Details
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

FAQ

  • What is Ieramilimab? Ieramilimab, also known as LAG525, is an investigational drug being studied for the treatment of advanced cancer. It is a type of protein called a monoclonal antibody that targets a specific molecule in the immune system.
  • What types of cancer is Ieramilimab being studied for? Ieramilimab is being studied for various types of advanced cancer. The clinical trials are not limited to a specific cancer type but focus on patients with different forms of advanced malignant neoplasms (cancers).
  • How is Ieramilimab administered? Ieramilimab is administered through intravenous (IV) use, which means it is given directly into a vein. It comes in the form of a concentrate for solution for infusion.
  • What is the main goal of the clinical trials involving Ieramilimab? The main objective of the clinical trials is to collect safety and tolerability data for Ieramilimab, both as a single agent and in combination with other study treatments. This helps researchers understand how well patients can tolerate the drug and what side effects may occur.
  • Who can participate in these clinical trials? Participants must be currently enrolled in a pre-defined Novartis-sponsored study and receiving Ieramilimab (spartalizumab) either alone or in combination with other treatments. They must be deriving clinical benefit from the treatment and have demonstrated compliance with the parent study's requirements.

Ongoing Clinical Trials on Ieramilimab

  • Study on the Safety and Tolerability of Spartalizumab for Patients with Advanced Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Hungary Italy +2

Glossary

  • Ieramilimab: An investigational drug, also known as LAG525, being studied for the treatment of advanced cancer. It is a monoclonal antibody that targets a specific molecule in the immune system.
  • Monoclonal antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. They can be used to detect or treat cancer.
  • Advanced cancer: Cancer that has spread from where it started to other parts of the body or has grown extensively in its original location.
  • Intravenous (IV) use: A method of administering medication directly into a vein using a needle or tube.
  • Concentrate for solution for infusion: A liquid medication that needs to be diluted before it can be given to a patient through an IV line.
  • Clinical trial: A research study that tests how well new medical approaches work in people.
  • Adverse events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious adverse events (SAEs): An adverse event that results in death, is life-threatening, requires hospitalization, causes a significant incapacity, or requires intervention to prevent permanent impairment.
  • Dose interruption: Temporarily stopping the administration of a medication.
  • Dose reduction: Decreasing the amount of medication given to a patient.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-spartalizumab-for-patients-with-advanced-cancer/