NCT07438847

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: SHAOYAN LIU · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of 177Lu-CTR-FAPI in patients with thyroid cancer. The study is designed to characterize the safety profile and dose-limiting toxicities (DLTs) in order to determine the maximum tolerated dose (MTD) of 177Lu-CTR-FAPI. Additionally, the study will assess biochemical responses, radiological responses and improvement of life quality as well as the dosimetry profile of this molecule. This is a multi-center, open-label, single-arm phase I trial using a classic "3+3" dose-escalation design. The starting dose is 100 mCi and increases in 50 mCi increments for subsequent cohort. The MTD is defined as the highest dose at which fewer than 33% of participants experience a DLT during the 6-week observation period following the first administration. A total of 12 eligible participants with thyroid cancer will be enrolled and receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks, for up to 4 cycles. Dose delays are permitted based on evaluation of treatment response or the necessity for recovery from adverse reactions, with a maximum delay of 12 weeks after the previous dose.

Conditions

• Thyroid Cancer

Interventions

Type	Name	Description
DRUG	177Lu-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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

2 sites across 1 country: China