Clinical trialPhase 1Recruiting
Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors
Phase I, Open Label First in Human Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of JFI447 [68Ga]Ga-DFC413, and Compare to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 23 June 2026
- Expected end
- 16 January 2028
- Enrollment
- 66 participants
- Sites
- 2
- Primary outcomes
- Part 1: Standard Uptake Value (SUV) of 68Ga-DFC413 uptake in organs and tumors over time; Part 1: Standard Uptake Value ratio (SUVr) of 68Ga-DFC413 uptake; Part 2: Agreement between 68Ga-DFC413 and 68Ga-NNS309 for assessing target lesions from both PET scans per disease group
- Sponsor
- Industry
- Results posted
- No
- Last update
- 27 August 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
This is a first-in-human (FiH), open-label, multicenter, phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, pharmacokinetics (PK), and dosimetry properties of 68Ga-DFC413 and to explore whether 68Ga-DFC413 can be used to identify FAP-expressing lesions in patients with various solid tumors, including metastatic PDAC, NSCLC, ductal and lobular BC, TNBC, CRC, and STS. The study is divided in 2 parts: An imaging characterization part (Part 1) and a comparative assessment part (Part 2). All patients in Part 1 (imaging characterization part) will receive a single administered radioactive dose of 68Ga-DFC413. In Part 2 (comparative assessment part) patients will either receive a single administered radioactive dose of 68Ga-DFC413 followed by a single administered radioactive dose of 68Ga-NNS309; or a single administered radioactive dose of 68Ga-NNS309 followed by 68Ga-DFC413.