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

NCT07438847 | Recruiting Phase 1 DMC

• 1 other identifier: BRP-010-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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

Thyroid Cancer

Keywords

Thyroid cancer; Radionuclide therapy; CTR-FAPI

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events, frequency of dose-limiting toxicities and maximum tolerated dose of 177Lu-CTR-FAPI in patients with thyroid cancer.

  Incidence and severity of adverse events, frequency of dose-limiting toxicities(DLTs) will be evaluated within the 6-week observation period following the first administration of 177Lu-CTR-FAPI. DLTs will be assesse based on Common Terminology Criteria for Adverse Events (CTCAE) 5.0. The Maximum Tolerated Dose (MTD) will be 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.

  From enrollment to 6 weeks after the first injection of 177Lu-CTR-FAPI.

Secondary Outcomes (10)

• Biochemical response rate

  From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.

• Duration of biochemical response

  From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.

• Radiological response rate

  From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.

• Duration of radiological response

  From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.

• Progression-free survival

  From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.

Study Arms (1)

177Lu-CTR-FAPI Arm

EXPERIMENTAL

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.

Drug: 177Lu-CTR-FAPI therapy

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.

177Lu-CTR-FAPI Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Evidence of progressive disease based on RECIST 1.1 criteria in pre-treatment imaging.
• Prior surgical resection of resectable cervical lesions, with currently unresectable systemic disease.
• 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).
• Positive CTR-FAPI uptake in lesions, defined as SUVmax \> 10 in more than half of the lesions on 68Ga-CTR-FAPI PET/CT.
• Life expectancy \> 6 months.
• ECOG performance status ≤ 2.
• 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).
• For subjects with fertility: agreement to use effective contraception during treatment and 4 months (males) or 7 months (females) after the last dose.
• Voluntary participation and signed informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• SHAOYAN LIU: lead
• Peking Union Medical College Hospital: collaborator
• Beijing Tsinghua Changgeng Hospital: collaborator
• Navy General Hospital, Beijing: collaborator

Study Sites (2)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100021, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Related Publications (2)

• Kong Z, Li Z, Cui XY, Wang J, Xu M, Liu Y, Chen J, Ni S, Zhang Z, Fan X, Huang J, Lin Y, Sun Y, He Y, Lin X, Meng T, Li H, Song Y, Peng B, An C, Gao C, Li N, Liu C, Zhu Y, Yang Z, Liu Z, Liu S. CTR-FAPI PET Enables Precision Management of Medullary Thyroid Carcinoma. Cancer Discov. 2025 Feb 7;15(2):316-328. doi: 10.1158/2159-8290.CD-24-0897.

  PMID: 39470165 BACKGROUND

• Cui XY, Li Z, Kong Z, Liu Y, Meng H, Wen Z, Wang C, Chen J, Xu M, Li Y, Gao J, Zhu W, Hao Z, Huo L, Liu S, Yang Z, Liu Z. Covalent targeted radioligands potentiate radionuclide therapy. Nature. 2024 Jun;630(8015):206-213. doi: 10.1038/s41586-024-07461-6. Epub 2024 May 22.

  PMID: 38778111 BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Yansong Lin, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Shaoyan Liu, M.D.

  Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziren Kong, M.D.

CONTACT

0086-18500487274; zrkong@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Head and Neck Surgery

Model Details: A total of 12 adult participants with thyroid cancer will receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks for up to 4 cycles. A standard "3+3" dose-escalation design is employed. The starting dose is 100 mCi, with subsequent dose levels increasing by 50 mCi increments. Dose delays are permitted based on recovery from adverse reactions and reatment response. Participants will undergo structured monitoring and follow-up visit to assess safety, efficacy, and long-term outcomes.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 27, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)