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

NCT07438847 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER
  • Beijing Tsinghua Changgeng Hospital

    collaborator OTHER
  • Navy General Hospital, Beijing

    collaborator OTHER
  • SHAOYAN LIU

    lead OTHER

Principal Investigators

  • Yansong Lin, M.D. · Peking Union Medical College Hospital

  • Shaoyan Liu, M.D. · Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07438847 on ClinicalTrials.gov