TheranosticTrials.org

Clinical Trial · NCT07438847

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

Overview

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.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase

Phase 1

Contacts

Ziren Kong, M.D. (CONTACT)

zrkong@126.com

0086-18500487274

Shaoyan Liu, M.D. (PRINCIPAL_INVESTIGATOR)

Yansong Lin, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07438847

Drug / Compound

CTR-FAPI

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Prior surgical resection of resectable cervical lesions, with currently unresectable systemic disease.
  • Prior anti-tumor therapy-related toxicities that recoverd to Grade 0 or 1 (except alopecia, pigmentation, or chronic radiation toxicities and deemed irreversible by the investigator).
  • Positive CTR-FAPI uptake in lesions, defined as SUVmax \> 10 in more than half of the lesions on 68Ga-CTR-FAPI PET/CT.
  • Evidence of progressive disease based on RECIST 1.1 criteria in pre-treatment imaging.
  • Histologically confirmed diagnosis of thyroid cancer according to the 2022 WHO classification of thyroid tumors. Differentiated thyroid carcinoma must be diagnosed as radioactive iodine-refractory (RAIR) by a nuclear medicine specialist.
  • Life expectancy \> 6 months.
  • For subjects with fertility: agreement to use effective contraception during treatment and 4 months (males) or 7 months (females) after the last dose.
  • ECOG performance status ≤ 2.
  • Previous targeted therapy was discontinued due to intolerance, or lack of benefit from targeted therapy assessed by investigator, or patient refusal.
  • At least one measurable target metastatic lesion on contrast-enhanced CT/MRI (longest diameter of lesion ≥ 10 mm or shortest diameter of lymph node ≥ 15 mm).

Exclusion

  • Any other condition deemed inappropriate for participation by the investigator (e.g., poor compliance, inability to cooperate with treatment and follow-up).
  • Participation in another drug or device clinical trial within 4 weeks before the first dose.
  • Surgery under general anesthesia within 8 weeks before the first dose.
  • Presence of CTR-FAPI-negative lesions (i.e., malignant lesions on contrast-enhanced CT/MRI without uptake on 68Ga-CTR-FAPI PET/CT).
  • Severe or uncontrolled comorbidities.
  • Insufficient major organ function.
  • Prior therapeutic radionuclide therapy (except 131I).
  • Active infection within 4 weeks before the first dose.
  • History of acute coronary syndrome or stroke within 8 weeks before the first dose.
  • History of symptomatic central nervous system metastases.
  • Women who are pregnant, breastfeeding, or planning pregnancy.
  • Other concurrent malignancies.
  • Systemic anti-cancer therapy (including chemotherapy, targeted therapy, immunotherapy, radionuclide therapy, or anti-tumor traditional Chinese medicine) within 4 weeks before the first dose.
  • Severe claustrophobia.
  • Presence of pleural effusion or ascites requiring intervention or judged uncontrolled by the investigator at screening.
  • Known allergy to contrast agents.