Can a radioactive 'Smart Bomb' target tough tumors?
NCT ID NCT07808177
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
Researchers are testing an experimental radioactive drug called 177Lu-FAP-VG11 in people with advanced solid tumors that have not responded to standard treatments. The drug is designed to seek out and attach to a protein called FAP, which is found on many tumor cells. This early study focuses on whether the drug is safe, how much can be given, and how it spreads through the body. The goal is to find a safe dose for future studies that might shrink tumors.
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 called 177Lu-FAP-VG11, given as an injection, that targets a protein (FAP) found on many solid tumors.
- What this could lead to
- If it works, this could lead to a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is a very early, small study focused on safety and dosing, not effectiveness. The drug may cause side effects or fail to shrink tumors, and results may not apply to all patients.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 7 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 years and older
- 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: * Patients with advanced solid tumors who have failed standard therapy or for whom no standard therapy is available. * Patients whose tumors are assessed as FAP-positive (high FAP expression with SUVmax uptake above liver background) by FAP-targeted diagnostic PET/CT imaging. * In the investigator's judgment, no other treatment option with curative or life-prolonging potential is available. * Male or non-pregnant, non-lactating females, aged ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status score ≤2. * Life expectancy \>6 months. * Female patients: Women of childbearing potential must agree to use highly effective contraceptive methods from screening until 6 months after the last dose of study drug. * Male patients: Subjects must use a condom during sexual intercourse during the study and for 14 weeks after the last study treatment to prevent partner pregnancy and to avoid transmission of the study drug via semen; in addition, subjects should refrain from sperm donation during treatment and for 6 months after the last study drug administration. * Subjects must provide written informed consent voluntarily before participation in the trial. * Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: * Clinically symptomatic central nervous system metastases or meningeal metastases, or other evidence that the patient's central nervous system or meningeal metastases are not controlled, and deemed unsuitable for enrollment by the investigator. * Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of study drug, or need for elective surgery during the study period. * History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or severe autoimmune disease history deemed unsuitable for enrollment by the investigator; or allogeneic organ transplantation requiring immunosuppressive therapy. * Receipt of systemic or local radioisotope therapy within 3 months prior to the first dose. * Receipt of other investigational drugs not yet marketed within 4 weeks prior to the first use of study drug, or within five half-lives of the other investigational drug. * Definitive history of neurological or psychiatric disorders, including epilepsy or dementia. * Pregnancy or lactation, or unwillingness to use adequate contraceptive methods. * Any severe concomitant disease that, in the investigator's opinion, would make the patient's participation in the study inadvisable or could affect compliance with the protoco.
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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 places running it
1 site. 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
Locations
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Cancer Hospital of Shandong First Medical University
RECRUITINGJinan, Shandong, 250000, China
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- Can a new gemcitabine formulation outsmart advanced solid tumors?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can a Two-Pronged drug attack Hard-to-Treat tumors?