Lead-212 PSV359 Therapy for Patients With Solid Tumors

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.

Interventions

• [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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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 administration
* Diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to enrollment into the study
* Current abuse of alcohol or illicit drugs
* Treatment with any live/attenuated vaccine in the 7 days prior to enrollment
* Previous treatment with any systemic anticancer therapy within 4 weeks prior to treatment on study

Sites (11)

• University of Miami, Miami, Florida · RECRUITING
• Biogenix, Miami, Florida · RECRUITING
• University of Kansas, Kansas City, Kansas · RECRUITING
• University of Kentucky, Lexington, Kentucky · RECRUITING
• Mayo Clinic in Rochester, Minnesota, Rochester, Minnesota · RECRUITING
• Saint Louis University, St Louis, Missouri · RECRUITING
• Nebraska Cancer Specialists, Omaha, Nebraska · RECRUITING
• Ohio State University, Columbus, Ohio · RECRUITING
• University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania · RECRUITING
• MD Anderson Cancer Center, Houston, Texas · RECRUITING
• University of Wisconsin, Madison, Wisconsin · RECRUITING