Lead-212 PSV359 Therapy for Patients With Solid Tumors (NCT06710756) | Clinical Trial Compass
RecruitingPhase 1/2
Lead-212 PSV359 Therapy for Patients With Solid Tumors
United States112 participantsStarted 2025-04-28
Plain-language summary
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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion Criteria:
* 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
* Progressive disease despite standard therapy or for whom no standard therapy exists
* Positive \[203Pb\]Pb-PSV359 SPECT/CT scan showing uptake of \[203Pb\]Pb-PSV359 in at least 1 known lesion on the 1-hour SPECT/ CT scan
* Histological, pathological, and/or cytological confirmation of solid tumor malignancy that is locally advanced or metastatic
Exclusion Criteria:
* Known hypersensitivity to the active agent or any of the excipients
* Active secondary malignancy
* Pregnancy or breastfeeding a child
* Known brain metastases
* Known active or uncontrolled infections requiring ongoing antifungals or antibiotics in the 3 days prior to enrollment
* Known medical condition which would make this protocol unreasonably hazardous for the patient
* Existence of any medical or social issues likely to interfere with study conductor that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions
* Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the investigational product or excipients
* Major surgery within 21 days prior to the administration of \[212Pb\]Pb-PSV359; the subject must be sufficiently recovered and stable before treatment administrat…
What they're measuring
1
Determination of safety and tolerability of [203Pb]Pb-PSV359
Timeframe: 30 days (±1day) post dose
2
Determination of safety and tolerability of [212Pb]Pb-PSV359
Timeframe: Up to 3 years
3
To determine the recommended phase 2 dose of [212Pb]Pb-PSV359