This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of \[68Ga\]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive/HER2 negative (HR+/HER2-) and HER2 positive (HER2+) advanced breast cancer (aBC) and advanced Non-Small Cell Lung Cancer (aNSCLC) adenocarcinoma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years old
* Patients with histologically or cytologically confirmed and documented HR+/HER2- advanced breast cancer (aBC), advanced defined as locoregionally advanced unresectable or metastatic, either untreated or currently receiving first line of systemic therapy OR patients with histologically or cytologically confirmed and documented HER2+ aBC, advanced defined as locoregionally advanced unresectable or metastatic, either untreated or relapsed/refractory (r/r) after one or more lines of treatment OR patients with histologically or cytologically confirmed and documented advanced NSCLC (aNSCLC) adenocarcinoma, advanced defined as locoregionally unresectable or metastatic, either untreated or currently receiving first line of systemic therapy.
* Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional CT scan.
Exclusion Criteria:
* Patients having out of range laboratory values for kidney function and blood markers as defined in the study protocol
* Patients with inadequate hepatic function
* Unmanageable urinary tract obstruction or urinary incontinence
Other protocol-defined inclusion/exclusion criteria may apply.
Primary outcome measure(s)
Standard Uptake Value (SUV) mean and max of FKL480 uptake in normal organs and tumor lesions over time — Up to 240 minutes after dosing on Day 1 Imaging properties of FKL480 will be evaluated by assessing radiotracer uptake, identified via positron emission tomography (PET) scans. The SUVmean and SUVmax will be calculated and reported with summary statistics.
Standard Uptake Value ratio (SUVr) of FKL480 uptake in normal organs and tumor lesions over time — Up to 240 minutes after dosing on Day 1 SUVr will be calculated by dividing the SUV of the lesions by the SUV of the different organs in order to identify the reference organ with the lowest uptake and the respective SUVr (i.e. using SUVmean or SUVmax).
Trial sites (1)
Facility
City
Region
Status
Novartis Investigative Site
Groningen
Provincie Groningen
Recruiting
More Novartis Pharmaceuticals trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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