Actively Recruiting
Study of 177Lu-LNC1004 Injection in FAP-positive Radioiodine-refractory Differentiated Thyroid Cancer
Led by Peking Union Medical College Hospital · Updated on 2025-04-15
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
177Lu-LNC1004 Injection, a radiopharmaceutical targeting FAP, has demonstrated preliminary antitumor effect in advanced FAP-positive solid tumor patients. The primary purpose of this study is to evaluate the efficacy of 177Lu-LNC1004 Injection in patients with FAP-positive RAIR-DTC who have failed first-line TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles.
CONDITIONS
Official Title
Study of 177Lu-LNC1004 Injection in FAP-positive Radioiodine-refractory Differentiated Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent
- Age 18 years or older
- Diagnosed with RAIR-DTC confirmed by histology or cytology
- Failed TKIs treatment or refused standard therapy
- ECOG performance status score of 0 to 2
- At least one measurable lesion per RECIST 1.1
- Life expectancy of at least 6 months
- FAP-positive lesion confirmed by FAPI PET/CT scan
- Adequate bone marrow, liver, and kidney function as defined
- Recovery to Grade 1 or less from prior treatment toxic reactions
You will not qualify if you...
- Known central nervous system metastases unless asymptomatic or stable after treatment for at least 4 weeks
- Secondary malignancy within 5 years except certain cured localized cancers
- Antitumor treatment within 4 weeks before dosing
- Targeted therapy stopped less than 4 weeks or 10 half-lives before dosing
- Systemic radionuclide or radioembolization therapy within 6 months or external beam radiotherapy within 2 weeks before dosing
- Allergy to 177Lu-LNC1004 Injection or similar drugs
- Not fully recovered from major surgery or expecting major surgery during the study
- Severe cardiovascular or cerebrovascular diseases including recent interventions, serious arrhythmias, abnormal ECG, NYHA grade 3 or higher, recent severe events
- Active significant infections or untreated hepatitis or HIV
- Prior allogeneic hematopoietic stem cell or organ transplantation
- Pleural effusion or ascites requiring treatment or uncontrollable
- Mental illness or substance abuse affecting adherence
- Refusal to use effective contraception during and 6 months after treatment
- Pregnant or breastfeeding women or planning pregnancy during and 6 months after treatment
- Any other conditions deemed unsafe or interfering by investigator including certain lung diseases or urinary incontinence
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
Y
Yan-Song Lin, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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