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New treatment option for Pancreatic Ductal Adenocarcinoma
Official title Lead-212 PSV359 Therapy for Patients With Solid Tumors
ClinicalTrials.gov ID: NCT06710756
What this study is testing
What is [203Pb]Pb-PSV359?
[203Pb]Pb-PSV359 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic ductal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Kansas City, Kansas, United States; Lexington, Kentucky, United States; Rochester, Minnesota, United States; St Louis, Missouri, United States; Omaha, Nebraska, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.