RecruitingPhase 2NCT06222489

Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT


Sponsor

The Netherlands Cancer Institute

Enrollment

16 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Activity of patritumab deruxtecan (U3-1402; HER3-DXd) has been shown in a phase I/II study in patients with HER3 expressing breast cancer as well as in a phase I study in patients with EGFR TKI refractory EGFR mutation positive NSCLC with a preliminary ORR of 25%. HER3 expression can be seen in multiple tumor types and is therefore an attractive target for antibody drug conjugate (ADC) treatment. However, intra- and intertumor heterogeneity of HER3 expression might be substantial, as is seen for HER2, and might contribute to treatment failure or heterogeneous responses. In addition, HER3 expression is dynamic and has been shown to change over time. In order to identify patients that may benefit most from treatment with patritumab deruxtecan, better knowledge of the in vivo behaviour of the drug is warranted. One way to visualize this behaviour is positron emission tomography (PET) imaging with radiolabelled antibodies (immune-PET). 89Zr-Patritumab deruxtecan PET/CT can assess HER3 expression non-invasively at a whole body level, including sites that may be difficult to biopsy. It also visualizes and quantifies biodistribution of patritumab deruxtecan, thereby obtaining valuable information for safety and toxicity analyses.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a PET/CT scan with a specially labelled drug to measure how much of the HER3 protein is present throughout the whole body in people with advanced lung cancer that has a specific gene change (EGFR mutation). This will help predict who is most likely to respond to HER3-targeted treatment. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with advanced non-small cell lung cancer (NSCLC) with an EGFR mutation, confirmed by biopsy - You have received at least one prior EGFR-targeted therapy - Your blood counts, liver, and kidney function are adequate - You are willing to provide a tumor tissue sample **You may NOT be eligible if...** - You have or have had interstitial lung disease (lung scarring or inflammation) - You have a serious lung condition or immune disorder affecting the lungs - You have active brain metastases causing symptoms - You have had a heart attack or significant heart problems in the last 6 months - You are pregnant or breastfeeding - You have active hepatitis B, C, or HIV - You have previously received a HER3-targeted antibody-drug conjugate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG89Zr-Patritumab deruxtecan

Day 1, day 3, day 6, day 11 and day 26 of first course


Locations(1)

Antoni van Leeuwenhoek

Amsterdam, North Holland, Netherlands

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NCT06222489


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