RecruitingPhase 1NCT07438847

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


Sponsor

SHAOYAN LIU

Enrollment

12 participants

Start Date

Jan 1, 2026

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted radiation treatment called 177Lu-CTR-FAPI for people with thyroid cancer that no longer responds to standard treatments like radioactive iodine or targeted drug therapies. The treatment uses a special molecule that seeks out cancer cells and delivers radiation directly to them. **You may be eligible if...** - You have a confirmed diagnosis of thyroid cancer that has stopped responding to radioactive iodine treatment - Your cancer has measurable tumors on imaging scans - You have already had surgery to remove neck tumors that could be removed, but still have disease that cannot be surgically treated - A special PET scan shows your tumors absorb the targeting molecule strongly - You are generally well enough to carry out daily activities (performance status 0–2) - Your life expectancy is more than 6 months **You may NOT be eligible if...** - Some of your tumors do not show uptake on the special PET scan - You have had prior radiation therapy other than radioactive iodine - You recently had cancer treatment, major surgery, or heart attack/stroke (within 8 weeks) - You are pregnant or breastfeeding - You have active infections or uncontrolled medical conditions - You have brain metastases causing symptoms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG177Lu-CTR-FAPI therapy

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)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Peking Union Medical College Hospital

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT07438847


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