Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Breast cancer, Non-small cell lung cancer, Radioligand imaging, [68Ga]Ga-DWJ155, FKL480, gallium, adenocarcinoma, ductal, lobular, positron emission tomography (PET), dosimetry
Brief summary
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.
Detailed description
This is a first-in-human (FIH), open-label, phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, PK and dosimetry properties in patients with aBC and aNSCLC adenocarcinoma. Approximately 15-21 aBC and 9-15 aNSCLC patients will be enrolled into the study. All patients enrolled in the study will receive a single administered radioactive dose of FKL480. The study will consist of an imaging characterization part and an expansion part.
Interventions
DRUG[68Ga]Ga-DWJ155
Radioligand imaging agent
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Imaging study
Eligibility
Sex/Gender
ALL
Age
18 Years to 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 3 days after single dose administration on Day 1 | Incidence and severity of AEs and SAEs, including changes in vital signs and laboratory values qualifying and reported as AEs. |
| Dosimetry sub-group: Observed maximum concentration (Cmax) of FKL480 based on blood radioactivity data | Up to 240 minutes after dosing on Day 1 | The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples. |
| Dosimetry sub-group: Observed area under the curve (AUC) from time zero to the last measurable concentration sampling time (AUClast) of FKL480 based on blood radioactivity data | Up to 240 minutes after dosing on Day 1 | The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples |
| Dosimetry sub-group: Observed time to reach maximum (Tmax) after single dose administration of FKL480 based on blood radioactivity data | Up to 240 minutes after dosing on Day 1 | The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples |
| Dosimetry sub-group: Urinary excretion of FKL480 | Up to 240 minutes after dosing on Day 1 | The elimination of the compound in urine will be evaluated based on urine radioactivity concentration data obtained by measuring in gamma counting equipment the urine samples. |
| Dosimetry sub-group: Absorbed radiation dose in normal tissues and total body | Up to 240 minutes after dosing on Day 1 | Absorbed radiation dose coefficients in selected organs and lesions and total body as measured by image quantification. |
| Dosimetry sub-group: Effective dose | Up to 240 minutes after dosing on Day 1 | Effective dose in selected organs and total body as measured by image quantification. |
Countries
Netherlands
Contacts
CONTACTNovartis Pharmaceuticals
Outcome results
None listed