Phase I/IIa image-guided, alpha-particle therapy study of \[203Pb\]Pb-PSV359 and \[212Pb\]Pb-PSV359 in patients with solid tumors that are known to be Fibroblast Activation Protein (FAP)-positive.
Aged ≥ 18 years
Satisfactory organ function as determined by laboratory testing
Eastern Cooperative Oncology Group performance (ECOG) status of 0 to 1
Life expectancy > 3 months
Known hypersensitivity to the active agent or any of the excipients
Active secondary malignancy
Pregnancy or breastfeeding a child
Known brain metastases
Sequential
[203Pb]Pb-PSV359
Drug\[203Pb\]Pb-PSV359 is administered by intravenous bolus injection for single-photon emission computed tomography imaging.
[212Pb]Pb-PSV359
Drug\[212Pb\]Pb-PSV359 is administered by intravenous infusion for treatment of FAP expressing cancers.
Determination of safety and tolerability of [203Pb]Pb-PSV359
Incidence and severity of treatment-related adverse events following a single administration of \[203Pb\]Pb-PSV359 is determined
Determination of safety and tolerability of [212Pb]Pb-PSV359
Incidence and severity of treatment-related adverse events following a single and each repeated administration of \[212Pb\]Pb-PSV359 is determined
To determine the recommended phase 2 dose of [212Pb]Pb-PSV359
The recommended phase 2 dose as determined by cohort observations and review by the Safety Monitoring Committee
Determination of duration of response following treatment with [212Pb]Pb-PSV359
Median duration of response for subjects receiving at least 1 administration of \[212Pb\]Pb-PSV359 is assessed by RECIST V1.1 criteria
Determination of progression free survival following treatment with [212Pb]Pb-PSV359
Progression free survival for subjects receiving at least 1 administration of \[212Pb\]Pb-PSV359 is assessed by RECIST V1.1 criteria
Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359
Blood radioactivity pharmacokinetic parameter such as area under the plasma concentration versus time curve (AUC) is determined.
Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359
Blood radioactivity pharmacokinetic parameter such as peak plasm concentration (Cmax) is determined
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