Lead-212 PSV359 Therapy for Patients With Solid Tumors

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1/Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

90 Years

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