Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress ?v?3 and ?v?5 Integrins.

Summary

Participation Requirements

Description

Approximately 40 patients (male and female) will be enrolled into the study, 20 patients with GBM and 20 patients with Her2+ BC that has metastasized to the brain. The study will have an imaging characterization part and an expansion part. In the imaging characterization part of the study, approxima...

Approximately 40 patients (male and female) will be enrolled into the study, 20 patients with GBM and 20 patients with Her2+ BC that has metastasized to the brain. The study will have an imaging characterization part and an expansion part. In the imaging characterization part of the study, approximately 12 patients will be enrolled, 6 with r/r GBM and 6 with Her2+ BC that has metastasized to the brain. Both parts of the study (imaging characterization and expansion) will include a dosimetry sub-group in which the distribution, pharmacokinetics (PK), radiation dosimetry and absorbed doses in tissue and tumor will be assessed. All patients enrolled in the study will receive a single dose of [68Ga]-FF58 and undergo [68Ga]-FF58 PET imaging at different timepoints on Day 1 as well as conventional imaging (high resolution CT or MRI). The estimated study duration for each individual patient is approximately 44 days (including screening period of 28 days and 14 days of follow-up (FU)).

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