New radioactive drug targets thyroid tumors in early trial
NCT ID NCT07438847
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new radioactive drug called 177Lu-CTR-FAPI in 12 people with thyroid cancer that has spread and is no longer responding to standard treatments. The main goals are to find a safe dose and see if the drug can shrink tumors or lower cancer markers in the blood. It is an experimental treatment, not a cure, and aims to control the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2027
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: * Histologically confirmed diagnosis of thyroid cancer according to the 2022 WHO classification of thyroid tumors. Differentiated thyroid carcinoma must be diagnosed as radioactive iodine-refractory (RAIR) by a nuclear medicine specialist. * Evidence of progressive disease based on RECIST 1.1 criteria in pre-treatment imaging. * Prior surgical resection of resectable cervical lesions, with currently unresectable systemic disease. * Previous targeted therapy was discontinued due to intolerance, or lack of benefit from targeted therapy assessed by investigator, or patient refusal. * At least one measurable target metastatic lesion on contrast-enhanced CT/MRI (longest diameter of lesion ≥ 10 mm or shortest diameter of lymph node ≥ 15 mm). * Positive CTR-FAPI uptake in lesions, defined as SUVmax \> 10 in more than half of the lesions on 68Ga-CTR-FAPI PET/CT. * Life expectancy \> 6 months. * ECOG performance status ≤ 2. * Prior anti-tumor therapy-related toxicities that recoverd to Grade 0 or 1 (except alopecia, pigmentation, or chronic radiation toxicities and deemed irreversible by the investigator). * For subjects with fertility: agreement to use effective contraception during treatment and 4 months (males) or 7 months (females) after the last dose. * Voluntary participation and signed informed consent. Exclusion Criteria: * Presence of CTR-FAPI-negative lesions (i.e., malignant lesions on contrast-enhanced CT/MRI without uptake on 68Ga-CTR-FAPI PET/CT). * Prior therapeutic radionuclide therapy (except 131I). * Systemic anti-cancer therapy (including chemotherapy, targeted therapy, immunotherapy, radionuclide therapy, or anti-tumor traditional Chinese medicine) within 4 weeks before the first dose. * Participation in another drug or device clinical trial within 4 weeks before the first dose. * Insufficient major organ function. * Severe or uncontrolled comorbidities. * Presence of pleural effusion or ascites requiring intervention or judged uncontrolled by the investigator at screening. * Active infection within 4 weeks before the first dose. * Women who are pregnant, breastfeeding, or planning pregnancy. * Known allergy to contrast agents. * History of symptomatic central nervous system metastases. * Other concurrent malignancies. * Surgery under general anesthesia within 8 weeks before the first dose. * History of acute coronary syndrome or stroke within 8 weeks before the first dose. * Severe claustrophobia. * Any other condition deemed inappropriate for participation by the investigator (e.g., poor compliance, inability to cooperate with treatment and follow-up).
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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
2 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
Locations
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National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITINGBeijing, 100021, China
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Peking Union Medical College Hospital
RECRUITINGBeijing, 100730, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a video keep thyroid cancer patients on track after surgery?
- Can doctors safely watch small thyroid cancers instead of removing them?
- Can heat replace the scalpel for small thyroid tumors?
- Thyroid surgery under the microscope: what 3,000 real operations reveal