177Lu-CTR-FAPI for the Treatment of Thyroid Cancer
177Lu-CTR-FAPI for the Treatment of Thyroid Cancer: A Prospective, Multi-center, Open-labeled, Single-arm, Phase I Study
SHAOYAN LIU
12 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
Summary
This is a multi-center, open-label, single-arm, dose-escalation phase I study, aiming to evaluate the safety and efficacy of 177Lu-CTR-FAPI (covalent targeted radioligand-fibroblast activation protein inhibitor), a novel radiopharmaceutical in the treatment of thyroid cancer. The primary endpoint of the study is the safety of 177Lu-CTR-FAPI, and the secondary endpoints include treatment response and dosimetry evaluation.
Eligibility
Inclusion Criteria11
- 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 Criteria16
- 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).
Interventions
177Lu-CTR-FAPI will be diluted in 100 mL of normal saline and administered via slow intravenous infusion over 20-30 minutes. Dose will be escalated according to a "3+3" design, starting at 100 mCi and increasing in 50 mCi increments for subsequent cohort. Vital signs will be measured before and after drug administration. Throughout the infusion period, subjects will be closely monitored for any associated symptoms and adverse reactions.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07438847