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Zirconium (89Zr) Patritumab Deruxtecan

This article discusses the use of Zirconium (89Zr) Patritumab Deruxtecan in clinical trials for patients with advanced EGFR mutation-positive lung cancer. The drug is being studied to evaluate its effectiveness in targeting HER3 proteins and to assess its potential as a treatment option for patients who have progressed on previous therapies. The trials aim to optimize imaging techniques and explore correlations between drug uptake and treatment outcomes.

Table of Contents

What is ZIRCONIUM (89ZR) PATRITUMAB DERUXTECAN?

ZIRCONIUM (89ZR) PATRITUMAB DERUXTECAN is an innovative medical product being studied for the treatment of advanced lung cancer. It is a radiolabeled version of a drug called patritumab deruxtecan. The radiolabeling with zirconium-89 (89Zr) allows doctors to track the drug’s movement in the body using a special imaging technique called PET/CT[1].

This medication is also known by its sponsor product code, 89Zr-U3-1402. It’s important to note that this is an investigational drug, which means it’s still being studied and is not yet approved for widespread use[1].

What conditions does it treat?

ZIRCONIUM (89ZR) PATRITUMAB DERUXTECAN is being studied for the treatment of advanced EGFR mutation-positive non-small cell lung cancer (NSCLC). This is a specific type of lung cancer that has mutations in a gene called EGFR (Epidermal Growth Factor Receptor) and has reached an advanced stage[1].

Specifically, this treatment is being investigated for patients who have:

  • Advanced stage NSCLC that is not suitable for curative treatment
  • Received at least one line of EGFR TKI (Tyrosine Kinase Inhibitor) treatment
  • If their tumor is positive for a specific mutation called T790M, they must have had prior treatment with a third-generation EGFR TKI[1]

How does it work?

ZIRCONIUM (89ZR) PATRITUMAB DERUXTECAN is a type of drug called an antibody-drug conjugate (ADC). It combines three key components:

  1. Patritumab: An antibody that targets a protein called HER3 on cancer cells
  2. Deruxtecan: A potent anti-cancer drug
  3. Zirconium-89: A radioactive isotope that allows the drug to be tracked in the body

The antibody part of the drug (patritumab) seeks out and attaches to HER3 proteins on cancer cells. This allows the anti-cancer drug (deruxtecan) to be delivered directly to the tumor. The addition of zirconium-89 enables doctors to use PET/CT scans to see where the drug goes in the body and how much accumulates in tumor tissues[1].

Clinical Trial Information

A clinical trial is currently underway to study ZIRCONIUM (89ZR) PATRITUMAB DERUXTECAN. The main goals of this trial are:

  • To find the best dose of non-radiolabeled patritumab deruxtecan to use with the radiolabeled version for optimal imaging
  • To measure how much of the drug accumulates in tumor tissues
  • To see how the drug’s uptake in tumors relates to treatment outcomes
  • To assess how the drug is distributed in different organs of the body[1]

Administration and Dosage

ZIRCONIUM (89ZR) PATRITUMAB DERUXTECAN is given as an intravenous bolus injection or IV infusion. This means it’s administered directly into a vein. The maximum dose being studied is 37 MBq (megabecquerels, a unit of radioactivity). The treatment period in the current study is up to 3 days[1].

Eligibility for Treatment

To be eligible for treatment with ZIRCONIUM (89ZR) PATRITUMAB DERUXTECAN in the current study, patients must meet several criteria, including:

  • Be 18 years or older
  • Have confirmed advanced EGFR mutation-positive NSCLC
  • Have received at least one line of EGFR TKI treatment
  • Have measurable disease according to specific criteria
  • Have adequate organ function

There are also several conditions that would exclude a patient from the study, such as a history of interstitial lung disease, certain heart conditions, or active hepatitis B or C infection[1].

Potential Side Effects and Precautions

As this is an investigational drug, all potential side effects are not yet known. However, based on the information provided and the nature of the treatment, some precautions and potential side effects to be aware of include:

  • Patients with a history of lung diseases or conditions may be at higher risk of complications
  • The drug may affect heart function, so patients with certain heart conditions are excluded from the study
  • Liver function will be monitored, as the drug may affect liver enzymes
  • Pregnant or breastfeeding women should not receive this treatment
  • Patients and their partners should use effective birth control during treatment and for several months after[1]

It’s important to note that as this is a radiolabeled drug, there may be additional precautions related to radiation exposure. Always discuss potential risks and side effects with your healthcare provider.

Aspect Details
Drug Name Zirconium (89Zr) Patritumab Deruxtecan
Target Condition Advanced EGFR mutation-positive non-small cell lung cancer (NSCLC)
Study Type Phase 2, single-arm study
Primary Objective Identify optimal imaging dose for 89Zr-Patritumab Deruxtecan PET imaging
Secondary Objectives Quantify tumor uptake, correlate with HER3 expression and treatment outcomes, assess drug biodistribution
Key Eligibility Criteria Adults with advanced EGFR mutation-positive NSCLC, prior EGFR TKI treatment, measurable disease
Administration Intravenous bolus injection or IV infusion, maximum 37 MBq daily and total dose
Imaging Technique PET/CT with 89Zr-Patritumab Deruxtecan

FAQ

  • What is Zirconium (89Zr) Patritumab Deruxtecan? Zirconium (89Zr) Patritumab Deruxtecan is a radiolabeled version of Patritumab Deruxtecan, an antibody-drug conjugate targeting HER3 proteins in cancer cells. It is being studied for use in PET/CT imaging to help visualize and quantify HER3 expression in the body of patients with advanced EGFR mutation-positive lung cancer.
  • Who is eligible for these clinical trials? Eligible participants are adults (18 years or older) with histologically or cytologically confirmed advanced stage EGFR mutation-positive non-small cell lung cancer (NSCLC) who have received at least one line of EGFR TKI treatment. They must have measurable disease according to RECIST 1.1 criteria and adequate organ function.
  • What is the main objective of the clinical trial? The main objective is to identify the optimal dose of non-radiolabeled Patritumab Deruxtecan to be co-injected with 89Zr-Patritumab Deruxtecan for optimal PET imaging. The trial also aims to quantify tumor uptake of the drug and correlate it with HER3 expression and treatment outcomes.
  • What are some of the exclusion criteria for the trial? Some key exclusion criteria include a history of interstitial lung disease, unresolved toxicities from previous cancer therapies, significant cardiovascular disease, active hepatitis B or C infection, pregnancy or breastfeeding, and prior treatment with an HER3 antibody or antibody-drug conjugate containing an exatecan derivative.
  • How is the drug administered in the trial? Zirconium (89Zr) Patritumab Deruxtecan is administered as an intravenous bolus injection or IV infusion. The maximum daily dose is 37 MBq (megabecquerels), with a maximum total dose of 37 MBq over a treatment period of up to 3 days.

Ongoing Clinical Trials on Zirconium (89Zr) Patritumab Deruxtecan

  • Study on Patritumab Deruxtecan and Zirconium (89Zr) Patritumab Deruxtecan for Patients with Advanced EGFR Mutation Positive Lung Cancer

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • EGFR: Epidermal Growth Factor Receptor, a protein found on the surface of some cells that can become overactive in certain types of cancer, including some lung cancers.
  • HER3: Human Epidermal Growth Factor Receptor 3, a protein that is part of the same family as EGFR and can be involved in cancer growth.
  • NSCLC: Non-Small Cell Lung Cancer, the most common type of lung cancer, accounting for about 80-85% of all cases.
  • PET/CT: Positron Emission Tomography/Computed Tomography, an imaging technique that combines PET and CT scans to provide detailed pictures of the body's structures and functions.
  • 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.
  • TKI: Tyrosine Kinase Inhibitor, a type of targeted therapy that blocks specific enzymes involved in cancer growth.
  • Antibody-drug conjugate: A type of cancer treatment that combines an antibody (which targets specific cancer cells) with a drug designed to kill those cells.
  • Radiolabeled: A molecule or compound that has been tagged with a radioactive isotope, allowing it to be tracked and imaged in the body.
  • SUV: Standardized Uptake Value, a measure used in PET imaging to quantify the concentration of radiotracer in a specific area of the body.
  • Megabecquerel (MBq): A unit of measurement for radioactivity, equal to one million decays per second.

References

  1. http://clinicaltrials.eu/trial/study-on-patritumab-deruxtecan-and-zirconium-89zr-patritumab-deruxtecan-for-patients-with-advanced-egfr-mutation-positive-lung-cancer/