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68Ga-DFC413 · 1 trial · 7 indications
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.
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).
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.
| Arm | Type | Description |
|---|---|---|
| Part 1: Imaging Characterization | EXPERIMENTAL | Single dose of 68Ga-DFC413 |
| Part 2: Comparative Assessment | EXPERIMENTAL | Single dose of 68Ga-DFC413 followed by 68Ga-NNS309; or single dose of 68Ga-NNS309 followed by 68Ga-DFC413 |
| Name | Type | Description |
|---|---|---|
| 68Ga-DFC413 | DRUG | Radioimaging agent |
| 68Ga-NNS309 | DRUG | Radioimaging agent |
Inclusion Criteria: Patients eligible for inclusion in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Age ≥ 18 years old. 3. ECOG performance status ≤ 2. 4. Patients with one of the following indications (rega...
68Ga-DFC413 is an investigational small molecule imaging agent being developed by Novartis AG (ticker NVS) for use in oncology. It is a gallium-68 labeled radiotracer studied in patients with solid tumors, including metastatic pancreatic ductal adenocarcinoma. It is in Phase 1 clinical development and has not been approved by the FDA.
68Ga-DFC413 is being studied as a PET imaging radiotracer in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) and other solid tumors. The Phase 1 trial is designed to evaluate the agent in biomarker-selected patients. It is investigational and is not approved for any indication.
68Ga-DFC413 is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the Phase 1 study evaluating the radiotracer in patients with solid tumors, including metastatic pancreatic ductal adenocarcinoma.
68Ga-DFC413 is in Phase 1 clinical development. One Phase 1 trial is currently recruiting participants, and no trials have been completed. The study is enrolling 66 patients and is not yet FDA approved; the agent remains investigational.
68Ga-DFC413 is being evaluated in the Phase 1 trial NCT07630961, titled a Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors. The trial is recruiting 66 adults across sites in Denmark and Japan and includes patients with metastatic pancreatic ductal adenocarcinoma and other solid tumors.
Yes. 68Ga-DFC413 is also referred to as JFI447 [68Ga]Ga-DFC413, the name used in its Phase 1 trial title. Both names refer to the same investigational gallium-68 labeled radiotracer being developed by Novartis AG for solid tumors, including metastatic pancreatic ductal adenocarcinoma.