Smart radiation seeks out cancer cells in 8 tumor types
NCT ID NCT06710756
First seen Jun 25, 2026 · Last updated Jul 07, 2026 · Updated 3 times
Summary
This study tests a new drug that delivers a tiny dose of radiation directly to cancer cells that have a specific marker called FAP. The trial involves 112 adults with advanced cancers of the pancreas, stomach, esophagus, colon, ovary, head/neck, sarcoma, or mesothelioma. First, a small imaging dose is given to see if the drug reaches the tumors. Then, a treatment dose is given to try to shrink the cancer. The goal is to find a safe dose and see if it helps control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A radioactive drug (lead-212 attached to a targeting molecule) that seeks out and delivers radiation to cancer cells with a specific marker (FAP).
- What this could lead to
- If it works, this could offer a new treatment option for several hard-to-treat cancers that have not responded to standard therapies.
- What could go wrong
- This is an early-phase trial (phase I/IIa) with a small number of participants, so safety and effectiveness are not yet proven. The treatment involves radiation, which may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 112 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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May 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Biogenix
RECRUITINGMiami, Florida, 33165, United States
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Mayo Clinic in Rochester, Minnesota
RECRUITINGRochester, Minnesota, 55905, United States
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Nebraska Cancer Specialists
RECRUITINGOmaha, Nebraska, 68130, United States
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Ohio State University
RECRUITINGColumbus, Ohio, 43221, United States
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Saint Louis University
RECRUITINGSt Louis, Missouri, 63110, United States
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University of Kansas
RECRUITINGKansas City, Kansas, 66205, United States
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University of Kentucky
RECRUITINGLexington, Kentucky, 40536, United States
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University of Miami
RECRUITINGMiami, Florida, 33125, United States
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University of Pittsburgh Medical Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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University of Wisconsin
RECRUITINGMadison, Wisconsin, 53792, United States
Contact Email: •••••@•••••
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