Clinical trialEPhase 1Terminated
Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.
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.
- Outcome
- Stopped earlyBusiness reasons (Business decision)
- Phase
- EPhase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 14 October 2021
- Expected end
- 1 July 2024
- Enrollment
- 14 participants
- Sites
- 2
- Primary outcomes
- Time-activity curves (TACs) from 68Ga-FF58 PET/CT images; Standard Uptake Value (SUV) mean and max in lesions detected by PET scans; Tumor to Background Ratio (TBR) of lesions detected by PET scans
- Sponsor
- Industry
- Results posted
- No
- Last update
- 10 October 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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 imaging characterization part and an expansion part. In the imaging characterization part, approximately 24 patients were planned to be enrolled, 6 with r/r GBM, 6 with BC that had metastasized to the brain, 6 with GEA and 6 with PDAC. Due to the early termination of the study, the expansion part was not started. Both parts of the study (imaging characterization and expansion) included a dosimetry sub-group in which the distribution, pharmacokinetics (PK), radiation dosimetry and absorbed doses in tissue and tumor were to be assessed. However, no patients were enrolled in the dosimetry sub-group. All patients enrolled in the study received a single dose of \[68Ga\]-FF58 and underwent \[68Ga\]-FF58 positron emission tomography (PET) imaging at different timepoints on Day 1 as well as conventional imaging (high resolution computed tomography (CT) or magnetic resonance imaging (MRI)). The estimated study duration for each individual patient was approximately 44 days (including screening period of 28 days and 14 days of follow-up (FU)).