New radioactive compound shows promise in targeting Hard-to-Treat cancers
NCT ID NCT07587996
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a new radioactive drug called 177Lu-CTR-FAPI in 12 people with advanced solid tumors (breast cancer, sarcoma, or thyroid cancer) that had spread and no longer responded to standard treatments. The main goals were to see if the drug is safe and how it spreads in the body. The drug targets a protein called FAP, which is found in high amounts on these tumors, aiming to deliver radiation directly to cancer cells.
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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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12 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Apr 2026
- 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: * Pathological diagnosis confirmed metastatic solid tumors (breast cancer, sarcoma, and some thyroid cancers, etc.) that failed standard treatment or lacked standard treatment * Age: 75 ≥ age ≥ 18 years * ECOG score: 0 - 2 * 68Ga-CTR-FAPI PET/CT confirmed high expression of FAP in the tumor (more than 50% of the lesions with SUVmax ≥ 10) * The FAP immunohistochemical score of tumor cells is ≥ 2 (except for thyroid cancer) * There is at least one measurable lesion (RECIST 1.1) * Organ/marrow functions meet the specified thresholds, and there are no severe electrocardiogram abnormalities (QTcF ≤ 470ms) Exclusion Criteria: * There is brain metastasis or other central nervous system lesions. * The expected survival period is less than 6 months. * Within 4 weeks before administration, the patient has received chemotherapy, targeted therapy, immunotherapy, or other anti-tumor treatments or investigational drugs. * The patient has previously received other systemic radionuclide therapy (excluding 131I treatment for thyroid cancer). * There is uncontrolled pleural effusion, ascites, severe cardiovascular or cerebrovascular diseases, or infection.
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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.
Contacts and locations
Locations
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The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, 730000, China
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