Lead-212 PSV359 Therapy for Patients With Solid Tumors

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 atleast 1 known lesion on the 1-hour SPECT/ CT scan

• Histological, pathological, and/or cytological confirmation of solid tumormalignancy 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 antibioticsin the 3 days prior to enrollment

• Known medical condition which would make this protocol unreasonably hazardous forthe patient

• Existence of any medical or social issues likely to interfere with study conductorthat may cause increased risk to the subject or to others, e.g., lack of ability tofollow radiation safety precautions

• Medical history of a condition resulting in a severe allergic reaction such asanaphylaxis or angioedema to known components of the investigational product orexcipients

• Major surgery within 21 days prior to the administration of [212Pb]Pb-PSV359; thesubject must be sufficiently recovered and stable before treatment administration

• Diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior toenrollment 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 totreatment on study