Status:
TERMINATED
Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Glioblastoma Multiforme
Brain Neoplasms
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a First-In-Human (FIH) study of \[68Ga\]-FF58 to characterize the imaging properties, safety, biodistribution and dosimetry properties of \[68Ga\]-FF58 in adults with relapsed or refractory (r...
Detailed Description
Approximately 80 patients were planned to be enrolled into the study, 20 patients with GBM, 20 patients with BC that had metastasized to the brain, 20 with GEA and 20 with PDAC. The study included an...
Eligibility Criteria
Inclusion
- Signed informed consent must be obtained prior to participation in the study
- Patients with histologically or cytologically confirmed and documented r/r GBM that has progressed after prior radiation therapy and have not received prior bevacizumab OR patients with BC that has metastasized to the brain and who should have at least one newly diagnosed brain metastasis that has not been resected or irradiated, or has been irradiated and progressed OR patients with histologically or cytologically confirmed and documented locally advanced or metastatic GEA (i.e., adenocarcinoma of the stomach (intestinal subtype), esophagus, or gastroesophageal junction), either untreated or r/r after one or more lines of treatment OR patients with histologically or cytologically confirmed and documented locally advanced or metastatic PDAC, either untreated or r/r after one or more lines of treatment.
Exclusion
- Creatinine clearance (calculated using Cockcroft-Gault formula) \<40 mL/min.
- Unmanageable bladder outflow obstruction or urinary incontinence.
- QTcF \> 480 msec on screening ECG or congenital long QT syndrome.
- Any condition that requires chronic treatment with anticoagulants or antiplatelet agents
- Patients with a known bleeding disorder
- Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \[68Ga\]-FF58.
- Pregnant women. Women who are breastfeeding must express and discard breast milk for 12 hours after \[68Ga\]-FF58 administration and must also stop breast feeding during this same period. Males and females must abstain from sexual intercourse for 12 hours after \[68Ga\]-FF58 administration.
- 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 x ULN, except for patients that have tumor involvement of the liver, who are excluded if ALT \> 5 x ULN
- Aspartate aminotransferase (AST) \> 3 x ULN, except for patients that have tumor involvement of the liver, who are excluded if AST \> 5 x ULN
Key Trial Info
Start Date :
October 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04712721
Start Date
October 14 2021
End Date
July 1 2024
Last Update
October 10 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Lyon, France, 69373
2
Novartis Investigative Site
Essen, Germany, 45147