RecruitingEarly Phase 1NCT06898437

Study of 177Lu-LNC1004 Injection in FAP-positive Radioiodine-refractory Differentiated Thyroid Cancer

Clinical Trial to Evaluate the Antitumor Efficacy and Safety of 177Lu-LNC1004 Injection in Patients With Fibroblast Activating Protein (FAP)-Positive Radioiodine-refractory Differentiated Thyroid Cancer (RAIR-DTC) Who Have Failed TKIs Treatment or Refuse Standard Treatment


Sponsor

Peking Union Medical College Hospital

Enrollment

20 participants

Start Date

Mar 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new radioactive drug therapy called 177Lu-LNC1004 for people with thyroid cancer that has stopped responding to radioactive iodine treatment (a condition called radioiodine-refractory differentiated thyroid cancer, or RAIR-DTC). The drug targets a protein called FAP that is found on cancer cells, delivering radiation directly to the tumor. This is an early-phase study to assess safety and early signs of effectiveness. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with differentiated thyroid cancer that no longer responds to radioactive iodine - You have already tried or refused standard targeted therapy (TKIs such as lenvatinib or sorafenib) - Your cancer shows FAP-positive lesions on a special PET/CT scan - You have at least one measurable tumor and adequate organ function - Your general health score (ECOG) is 0, 1, or 2 **You may NOT be eligible if...** - Your cancer does not show FAP-positive lesions on imaging - You have active brain metastases causing symptoms - You have severe kidney, liver, or bone marrow dysfunction - You are pregnant or breastfeeding - You have had recent radiation to major bones (such as more than 25% of the skeleton) 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-LNC1004 Injection

Intravenous administration: a single dose of 80 mCi per Cycle


Locations(1)

Peking Union Medical College Hospital

Beijing, China

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NCT06898437


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