drugset / Trial / NCT07630961

Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors

NCT07630961 ↗

Phase 1 Recruiting 66 enrolled Novartis Pharmaceuticals
Non-randomizedSequentialOpen-labelDiagnostic

Summary

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.

Timeline

Start
2026-06-23
Primary completion
2028-01-22
Completion
2028-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject 68Ga-DFC413 Diagnostic / imaging agent — —
Subject 68Ga-NNS309 Diagnostic / imaging agent — —