The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of \[68Ga\]Ga-DFC413, and in Part 2 compare to \[68Ga\]Ga-NNS309 in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC), colorectal cancer (CRC), and soft tissue sarcoma (STS). In Part 2 of this study (comparison of \[68Ga\]Ga-DFC413 and \[68Ga\]Ga-NNS309), not all indications might be explored.
Signed informed consent must be obtained prior to participation in the study.
Age ≥ 18 years old.
ECOG performance status ≤ 2.
Patients must have at least one measurable lesion per RECIST v1.1 as measured by local Investigator (by conventional MRI or CT scan).
Estimated glomerular filtration rate < 60 mL/min (calculated using CKD-EPI 2021 formula, or measured based on 24-hour urine collection)
Total bilirubin > 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN) or direct bilirubin > 1.5 x ULN
Alanine aminotransferase (ALT) > 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT > 5.0 x ULN
Aspartate aminotransferase (AST) > 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if AST > 5.0 x ULN
Sequential
68Ga-DFC413
DrugRadioimaging agent
68Ga-NNS309
DrugRadioimaging agent
Part 1: Standard Uptake Value (SUV) of 68Ga-DFC413 uptake in organs and tumors over time
Imaging properties of 68Ga-DFC413 will be evaluated by assessing radiotracer uptake, identified via positron emission tomography (PET) scans. The SUV values will be calculated and reported with summary statistics.
Part 1: Standard Uptake Value ratio (SUVr) of 68Ga-DFC413 uptake
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).
Part 2: Agreement between 68Ga-DFC413 and 68Ga-NNS309 for assessing target lesions from both PET scans per disease group
Agreement between target lesions and normal organs from 68Ga-DFC413 and 68Ga-NNS309 PET imaging will be assessed using summary statistics of SUV and SUVr.
Part 1: Observed maximum concentration (Cmax) of 68Ga-DFC413 based on blood radioactivity data
The pharmacokinetic analysis of 68Ga-DFC413 will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples.
Part 1: Time to reach maximum concentration (Tmax) of 68Ga-DFC413 based on blood radioactivity data
The pharmacokinetic analysis of 68Ga-DFC413 will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples.
Part 1: Area under the concentration-time curve (AUC) of 68Ga-DFC413 based on blood radioactivity data
The pharmacokinetic analysis of 68Ga-DFC413 will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples.
Part 1: Urinary excretion of 68Ga-DFC413
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.
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