Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- France and Germany2 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Early phase 1
- People taking part
- 14 people enrolled
- Started
- 14 Oct 2021
- Ended
- 1 Jul 2024
- Type of study
- Interventional, 4 groups
- Treatments tested
- 68Ga-FF58
- Record updated
- 10 October 2025
- Why it stopped
- Business reasons
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Any condition that requires chronic treatment with anticoagulants or antiplatelet agents
- Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of [68Ga]-FF58
- Patients with a known bleeding disorder
- Creatinine clearance (calculated using Cockcroft-Gault formula) <40 mL/min
- QTcF > 480 msec on screening ECG or congenital long QT syndrome
- 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
- Unmanageable bladder outflow obstruction or urinary incontinence
- 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
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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/r) glioblastoma multiforme (GBM), breast cancer (BC) that has metastasized to the brain, gastroesophageal adenocarcinoma (GEA) or pancreatic ductal adenocarcinoma (PDAC) expected to overexpress alpha-v beta 3 (αvβ3) and alpha-v beta 5 (αvβ5) integrins.
The 4 groups in the trial
- Glioblastoma MultiformeTreatment being tested
All eligible participants will receive recommended dose of \[68Ga\]-FF58 of 3 Megabecquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
Treatment: 68Ga-FF58
- Brain Metastasis from Breast CancerTreatment being tested
All eligible participants will receive recommended dose of \[68Ga\]-FF58 of 3 Megabecquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
Treatment: 68Ga-FF58
- Gastroesophageal adenocarcinomaTreatment being tested
All eligible participants will receive recommended dose of \[68Ga\]FF58 of 3 Megabecquerel (MBq)/Kg (+/-10%) \[but not more than 250 and not less than 150 MBq\]
Treatment: 68Ga-FF58
- Pancreatic ductal adenocarcinomaTreatment being tested
All eligible participants will receive recommended dose of \[68Ga\]FF58 of 3 Megabecquerel (MBq)/Kg (+/-10%) \[but not more than 250 and not less than 150 MBq\]
Treatment: 68Ga-FF58
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phase I, Open-label, Multicenter Study to Evaluate the Imaging Performance, Safety, Biodistribution and Dosimetry of [68Ga]-FF58 in Adult Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.
- Record updated
- 10 October 2025