XCancer
Novartis

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

Description:

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.

Sponsor:

Novartis

Phase:

Phase 1

Contacts:

Novartis Pharmaceuticals (CONTACT)

novartis.email@novartis.com

1-888-669-6682

Novartis Pharmaceuticals (CONTACT)

+41613241111

Government Study Link:

NCT07630961 - Click here to see study on

ClinicalTrials.gov

DFC413

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Inclusion
  • Age ≥ 18 years old.
  • Patients eligible for inclusion in this study must meet all of the following criteria:
  • ECOG performance status ≤ 2.
  • Patients with one of the following indications (regardless of lines of prior therapy): Locally advanced unresectable or metastatic PDAC, NSCLC, HR+/HER2- ductal or lobular BC, TNBC, CRC or STS.
  • Signed informed consent must be obtained prior to participation in the study.
Exclusion
  • 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
  • Patients meeting any of the following criteria are not eligible for inclusion in this study:
  • 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
  • Out-of-range laboratory values defined as: