Actively Recruiting
Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT
Led by The Netherlands Cancer Institute · Updated on 2025-03-06
16
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent before any study procedures
- Have confirmed advanced EGFR mutation positive NSCLC not suitable for curative treatment
- Have measurable disease according to RECIST 1.1
- Have at least two lesions with a longest diameter of 2 cm or more
- Have received at least one prior line of EGFR TKI treatment for advanced NSCLC
- If tumor is positive for T790M mutation, prior treatment with a third generation EGFR TKI is required
- Be 18 years of age or older
- Eastern Cooperative Oncology Group performance status of 0 or 1 at screening
- Adequate bone marrow and organ function within 14 days prior to treatment start
- Willing to provide a qualifying tumor tissue specimen (pretreatment biopsy or archival tissue)
- Female participants of childbearing potential must have a negative pregnancy test and use highly effective birth control during and for 7 months after treatment
- Female participants must not donate or retrieve ova during the study and for 7 months after final dose
- Male participants must be surgically sterile or use highly effective birth control during and for 4 months after treatment
- Male participants must not freeze or donate sperm during the study and for 4 months after final dose
You will not qualify if you...
- History or current evidence of interstitial lung disease, including pulmonary fibrosis or radiation pneumonitis
- Severe pulmonary conditions such as severe asthma, COPD, restrictive lung disease, or pleural effusion
- Autoimmune or inflammatory disorders affecting the lungs
- Use of chronic systemic corticosteroids over 10 mg prednisone or equivalent before treatment
- Presence of leptomeningeal disease
- Clinically significant corneal disease
- Severe or uncontrolled systemic illnesses that may affect safety or study compliance
- Active spinal cord compression or untreated symptomatic brain metastases
- Recent brain radiation or chemotherapy within specified washout periods
- Prior treatment with HER3 antibodies or certain antibody drug conjugates
- Unresolved toxicities from previous cancer treatments above specified severity
- Known hypersensitivity to study drug components
- Other recent malignancies except certain treated skin cancers or in-situ disease
- Uncontrolled cardiovascular diseases including specific cardiac abnormalities
- Active hepatitis B or C infection as defined
- Pregnancy, breastfeeding, or intent to become pregnant during the study
- Known HIV infection
- Any other clinically relevant illness or abnormality affecting safety or drug metabolism
- Live virus vaccination within 28 days before treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands, 1066CX
Actively Recruiting
Research Team
J
Joop de Langen, MD
CONTACT
M
Marianne Mahn, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here