A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
[68Ga]Ga-DWJ155
DrugRadioligand imaging agent
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Advanced breast cancerExperimental treatment 1 intervention
Group B: Advanced NSCLCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Standard Uptake Value (SUV) mean and max of FKL480 uptake in normal organs and tumor lesions over time
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.
Time frame
Up to 240 minutes after dosing on Day 12
Standard Uptake Value ratio (SUVr) of FKL480 uptake in normal organs and tumor lesions over time
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).
Time frame
Up to 240 minutes after dosing on Day 1Secondary outcomes
1
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs, including changes in vital signs and laboratory values qualifying and reported as AEs.
Time frame
Up to 3 days after single dose administration on Day 12
Dosimetry sub-group: Observed maximum concentration (Cmax) of FKL480 based on blood radioactivity data
The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples.
Time frame
Up to 240 minutes after dosing on Day 13
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
The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples
Time frame
Up to 240 minutes after dosing on Day 14
Dosimetry sub-group: Observed time to reach maximum (Tmax) after single dose administration of FKL480 based on blood radioactivity data
The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples
Time frame
Up to 240 minutes after dosing on Day 1Sponsors and contacts
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Source ClinicalTrials.gov