A 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
Study Identifier:
PSV359-001
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruiting
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Study Summary
To evaluate the safety and efficacy of peptide-based theranostic (therapeutic and diagnostic) radiopharmaceuticals, i.e. \[203Pb\]Pb-PSV359 and \[212Pb\]Pb-PSV359 targeting Fibroblast Activation Protein in subjects with solid tumors.
To investigate the safety, dosimetry, pharmacokinetics, and efficacy of [²¹²Pb]Pb-PSV359.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Ovarian
Pancreas
Renal
Solid Tumor
Digestive & Intestinal
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18 - 90 Years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Status
Recruitment on Hold
Condition(s) Treated at Site
Ovarian
Pancreas
Renal
Solid Tumor
Digestive & Intestinal