Radioactive injection targets Hard-to-Treat pancreatic tumors
NCT ID NCT07229768
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing a radioactive drug called 177Lu-CTR-FAPI in 4 people with advanced pancreatic cancer that has not responded to standard treatments. The drug is given intravenously every 6 weeks for up to 4 doses. Researchers are checking for safety, how much radiation reaches organs, and whether tumors shrink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 177Lu-CTR-FAPI injection (a radioactive drug that targets tumors)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced pancreatic cancer that has stopped responding to standard therapies.
- What could go wrong
- This is a very early, small trial with only 4 participants, so results may not apply broadly. The radioactive drug may cause side effects or not shrink tumors effectively.
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 4 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2026
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 to 85 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: * 1: Patients with unresectable, advanced, or metastatic solid tumors who have been histologically or cytologically confirmed, have failed standard treatment, lack standard treatment options, or refuse standard treatment. Preferred tumor types include pancreatic cancer, breast cancer, and soft tissue sarcoma, and must meet any of the following tumor-specific criteria: 1. Patients with advanced or metastatic TNBC who have progressed after or are intolerant to at least 2 lines of systemic therapy; 2. Patients with HER2-positive advanced or metastatic breast cancer who have progressed after or are intolerant to at least 2 lines of HER2-targeted therapy; 3. Patients with HR/HER2-negative advanced or metastatic breast cancer who have progressed after or are intolerant to at least 2 lines of systemic therapy; 4. Patients with advanced or metastatic high-grade soft tissue sarcoma (excluding chordoma) who have progressed after or are intolerant to at least 1 line of systemic therapy; 5. Patients with advanced or metastatic pancreatic cancer who have progressed after or are intolerant to at least 1 line of systemic therapy. * 2: Age \>= 18 years, regardless of sex; * 3: Able to understand and sign informed consent and willing and able to comply with study and follow-up procedures; * 4: ECOG performance status score of 0 or 1; * 5: FAP expression in tumor lesions confirmed positive by FAPI PET/CT; * 6: Agree to provide archived or fresh tumor tissue for immunohistochemical evaluation (if available); * 7: At least 1 measurable lesion according to RECIST 1.1 criteria; * 8: Previous anti-tumor toxicities recovered to grade 0-1; * 9: Organ function meets requirements before first administration; 1. Hematology: Absolute neutrophil count (ANC) \>= 1.5×10\^9/L; Hemoglobin (Hb) \>= 80 g/L; Platelet count (PLT) \>= 75×10\^9/L; 2. Liver function: Total bilirubin (TB) \<= 1.5×ULN; AST and ALT \<= 3×ULN, and if there is hepatic tumor metastasis, ALT and AST \<= 5×ULN; 3. Renal function: Creatinine clearance \>= 50 mL/min (Cockcroft-Gault formula); ECG: QTcF \<= 470 ms; * 10: Fertile subjects voluntarily use effective contraception during treatment and for 4 months (male) or 7 months (female) after the last dose of study drug. Exclusion Criteria: * 1: Subjects with brain metastases, meningiomas, or other central nervous system lesions at screening * 2: Severe allergy to contrast agents or claustrophobia * 3: Expected survival period \< 6 months * 4: Receipt of blood transfusion within 2 weeks before the first dose to meet the eligibility criteria * 5: Administration of systemic antitumor therapies (including targeted therapy, immunotherapy, traditional Chinese medicine antitumor treatment, chemotherapy, etc.) within 4 weeks prior to the first dose * 6: Participation in other clinical trials involving investigational drugs or devices within 4 weeks before the first dose * 7: Major surgery within 4 weeks before the first dose or planned major surgery during the study period * 8: Active bacterial, fungal, viral, or other infections requiring intravenous medication within 4 weeks before the first dose * 9: Previous systemic radionuclide therapy (excluding I-131 treatment for thyroid cancer) or external beam radiotherapy (EBRT) within 4 weeks prior to the first dose * 10: History of other malignancies within 5 years before the first dose * 11: Severe cardiovascular or cerebrovascular diseases, or poorly controlled diabetes * 12: Presence of pleural effusion or ascites requiring treatment or judged by the investigator as uncontrolled at screening * 13: Females who are pregnant or breastfeeding * 14: Subjects considered by the investigator to have poor compliance and inability to cooperate with treatment and follow-up at screening.
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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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Shanghai General Hospital
RECRUITINGShanghai, China
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