177Lu-CTR-FAPI for the Treatment of Thyroid Cancer

Sponsor
SHAOYAN LIU
Study ID
NCT07438847
Phase
PHASE1
Status
Recruiting
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Conditions

  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 177Lu-CTR-FAPI therapy — DRUG
    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.

Study Details

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.

Key Dates

First listed
Feb 27, 2026
Start date
Jan 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 177Lu-CTR-FAPI Arm
    Participants will receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks for up to 4 cycles. A standard "3+3" dose-escalation design will be utilized, with starting dose of 100mCi and subsequent dose levels increasing by 50 mCi increments. Dose delays are permitted based on the recovery from adverse reactions and treatment response.

Primary Outcome Measure

Incidence and severity of adverse events, frequency of dose-limiting toxicities and maximum tolerated dose of 177Lu-CTR-FAPI in patients with thyroid cancer. [ Time Frame: From enrollment to 6 weeks after the first injection of 177Lu-CTR-FAPI. ]

Central Contacts

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