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Boserolimab

Boserolimab (MK-5890) is an investigational drug being studied in clinical trials for the treatment of advanced solid tumors. This article explores the ongoing research on boserolimab, both as a standalone therapy and in combination with other drugs, to assess its safety, effectiveness, and potential benefits for patients with various types of cancer.

Table of Contents

What is Boserolimab?

Boserolimab, also known as MK-5890, is a new drug being studied for the treatment of advanced solid tumors[1]. Solid tumors are abnormal masses of tissue that don’t contain cysts or liquid areas. They can occur in many parts of the body, such as the lungs, breast, or colon. Boserolimab is currently in clinical trials, which means it’s being tested to determine its safety and effectiveness in treating cancer patients.

What Conditions Does Boserolimab Treat?

Based on the clinical trial information, Boserolimab is being studied to treat several types of cancer[1]:

  • Advanced solid tumors: This is a general term for cancers that form solid masses in the body.
  • Non-small cell lung cancer (NSCLC): This is the most common type of lung cancer, accounting for about 80-85% of all lung cancers.
  • Triple-negative breast cancer (TNBC): This is an aggressive type of breast cancer that doesn’t respond to hormonal therapy or medicines that target HER2 protein.

How is Boserolimab Administered?

Boserolimab is given to patients through an intravenous (IV) infusion[1]. This means the drug is delivered directly into the bloodstream through a vein. The treatment is typically given on Day 1 of each 3-week cycle, for up to 35 administrations (approximately 2 years).

Boserolimab in Combination Therapies

One of the exciting aspects of Boserolimab is its potential to work well with other cancer treatments. The clinical trial is testing Boserolimab in several combinations[1]:

  1. Boserolimab alone: To understand how the drug works by itself.
  2. Boserolimab + Pembrolizumab: Pembrolizumab (also known as Keytruda) is an immunotherapy drug that helps the immune system fight cancer cells.
  3. Boserolimab + Pembrolizumab + Pemetrexed + Carboplatin: This combination is being tested for non-small cell lung cancer. Pemetrexed (Alimta) and Carboplatin (Paraplatin) are chemotherapy drugs.
  4. Boserolimab + Pembrolizumab + Nab-paclitaxel: This combination is being tested for triple-negative breast cancer. Nab-paclitaxel (Abraxane) is a type of chemotherapy.

Clinical Trial Details

The clinical trial for Boserolimab (identified as NCT03396445) is a Phase 1 study[1]. Phase 1 trials are typically the first tests of a drug in humans, focusing on safety and determining the right dose. Key points about this trial include:

  • The trial is testing different doses of Boserolimab to find the safest and most effective dose.
  • Participants receive treatment in cycles, with each cycle lasting 3 weeks (except for the breast cancer group, which has 6-week cycles).
  • The trial is studying how Boserolimab works alone and in combination with other cancer drugs.
  • Researchers are looking at how well tumors respond to the treatment and how long the responses last.

Safety and Side Effects

As with all new drugs, understanding the safety and potential side effects of Boserolimab is a crucial part of the clinical trial[1]. The researchers are carefully monitoring for what they call Dose-Limiting Toxicities (DLTs). These are side effects that are severe enough to limit the dose of the drug that can be given. Some potential DLTs being watched for include:

  • Severe non-blood-related toxicities
  • Severe blood-related issues lasting 7 or more days
  • Severe decrease in platelets (cells that help blood clot)
  • Fever with a low white blood cell count (cells that fight infection)
  • Any side effect that causes a significant delay in treatment or leads to discontinuation of the drug

It’s important to note that not all patients will experience these side effects, and the trial is designed to find the safest dose to minimize these risks.

Pharmacokinetics of Boserolimab

The trial is also studying the pharmacokinetics of Boserolimab[1]. Pharmacokinetics refers to how the drug moves through the body – how it’s absorbed, distributed, metabolized, and eliminated. Researchers are measuring things like:

  • Area Under the Curve (AUC): This measures the total exposure to the drug over time.
  • Minimum Concentration (Cmin): The lowest level of the drug in the blood between doses.
  • Maximum Concentration (Cmax): The highest level of the drug in the blood after a dose.

Understanding these aspects helps researchers determine the best dosing schedule for the drug.

Aspect Details
Drug Name Boserolimab (MK-5890)
Administration Intravenous (IV) infusion
Target Conditions Advanced solid tumors, including non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC)
Study Arms 1. Boserolimab monotherapy
2. Boserolimab + Pembrolizumab
3. Boserolimab + Pembrolizumab + Pemetrexed + Carboplatin
4. Boserolimab + Pembrolizumab + Nab-paclitaxel
Primary Outcomes Safety assessment (Dose-limiting toxicities, Adverse events)
Secondary Outcomes Pharmacokinetics (AUC, Cmin, Cmax), Objective Response Rate (ORR)
Treatment Duration Up to 35 administrations (approximately 2 years)

FAQ

  • What is Boserolimab? Boserolimab, also known as MK-5890, is an investigational drug being studied for the treatment of advanced solid tumors. It is administered through intravenous (IV) infusion and is being tested both as a standalone therapy and in combination with other cancer treatments.
  • What types of cancer is Boserolimab being studied for? Boserolimab is being studied for various types of advanced solid tumors, including non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). The clinical trials are exploring its potential effectiveness in these and other solid tumor types.
  • How is Boserolimab administered in the clinical trials? In the clinical trials, Boserolimab is administered through intravenous (IV) infusion. The drug is given on Day 1 of each treatment cycle, which typically lasts 3 weeks. The treatment can continue for up to 35 administrations, which is approximately 2 years.
  • What other drugs is Boserolimab being combined with in the trials? Boserolimab is being studied in combination with several other drugs, including pembrolizumab (another immunotherapy drug), pemetrexed and carboplatin (chemotherapy drugs for non-small cell lung cancer), and nab-paclitaxel (a chemotherapy drug used in triple-negative breast cancer treatment).
  • What are the main goals of the Boserolimab clinical trials? The main goals of the Boserolimab clinical trials are to assess the safety of the drug, understand its pharmacokinetics (how the drug moves through the body), determine the appropriate dosage, and evaluate its effectiveness in treating advanced solid tumors. The trials also aim to identify any potential side effects or adverse events associated with the treatment.

Ongoing Clinical Trials on Boserolimab

  • Study on Pembrolizumab, Etoposide, and Cisplatin or Carboplatin for First-Line Treatment in Patients with Extensive-Stage Small Cell Lung Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    Austria Hungary Italy Poland Spain

  • Study of Pembrolizumab with Drug Combination for Patients with Advanced Non-Small Cell Lung Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    Hungary Italy Poland Spain

  • Study of Boserolimab, MK-0482, and Pembrolizumab for Patients with Advanced Non-Small Cell Lung Cancer Resistant to PD-(L)1 Therapy

    Not recruiting

    1 1 1
    Investigated drugs:
    Hungary Italy Poland Spain

Glossary

  • Boserolimab: An investigational drug (also known as MK-5890) being studied for the treatment of advanced solid tumors, administered through intravenous infusion.
  • Pembrolizumab: An immunotherapy drug used in combination with Boserolimab in some arms of the clinical trial.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Intravenous (IV) infusion: A method of administering medication directly into a vein using a needle or catheter.
  • Solid tumor: An abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign or malignant.
  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is one of the focus areas in the Boserolimab clinical trials.
  • Triple-negative breast cancer (TNBC): A type of breast cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. It is another focus area in the Boserolimab trials.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a dose reduction.
  • Adverse event (AE): Any undesirable experience associated with the use of a medical product in a patient.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a set of rules used to measure how well a cancer patient responds to treatment.
  • Area Under the Curve (AUC): A measure used in pharmacokinetics to represent the total drug exposure over time.
  • Cmin: The minimum concentration of a drug in the blood, usually measured just before the next dose is administered.
  • Cmax: The maximum concentration of a drug in the blood, usually measured shortly after the drug is administered.

References

  1. https://clinicaltrials.gov/study/NCT03396445