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AzTrials

Refractory Thyroid Gland CarcinomaPhase 1NCT05410821

Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Metastatic Radioactive Iodine Refractory Thyroid Cancer

A Phase 1 study testing 177Lu-DOTA-EB-FAPI 1 radionuclide therapy, 177Lu-DOTA-EB-FAPI 2 radionuclide therapy and 177Lu-DOTA-EB-FAPI 3 radionuclide therapy in people with Refractory Thyroid Gland Carcinoma and Refractory Thyroid Gland Papillary Carcinoma, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Increased fibroblast activation protein expression is positively correlated with the dedifferentiation and aggressiveness of thyroid cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with radioactive iodine refractory… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
177Lu-DOTA-EB-FAPI 1 radionuclide therapy, 177Lu-DOTA-EB-FAPI 2 radionuclide therapy and 177Lu-DOTA-EB-FAPI 3 radionuclide therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
15 Jun 2022to 27 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand and willingness to sign a written informed consent document.
  • Age 18 and older
  • Confirmed unresectable or metastatic radioactive iodine refractory thyroid cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis)
  • Progressive disease after TKIs treatment
  • Eastern Cooperative Oncology Group Performance Status ≤ 3
  • Participant must have completed prior therapy at least 2 weeks (washout period) prior to 68Ga-FAPI-46 PET/CT scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved below Grade 2 or baseline. Completion of entry into 68Ga-FAPI-46 study and completion of scan
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  • Hematologic parameters defined as:
  • Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL
  • Blood chemistry levels defined as:
  • AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 3 times ULN Creatinine ≤ 3 times ULN Able to remain motionless for up to 30-60 minutes per scan

Who cannot join

  • Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)
  • Participants with Class 3 or 4 NYHA Congestive Heart Failure
  • Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
  • Pregnant or lactating women
  • Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
  • Has an additional active malignancy requiring therapy within the past 2 years
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  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • Cannot undergo PET/CT scanning because of weight limits (350 lbs)
  • INR>1.2; PTT>5 seconds above UNL

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361000

Other trials in China

About this study

Official title: An Open-Label, Non-Randomized, Dose Escalation, Single-Center, Investigator-Initiated Trial to Determine the Safety, Dosimetry, and Preliminary Effectiveness of 177Lu-DOTA-EB-FAPI in Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With Progressive Disease After Tyrosine Kinase Inhibitors Treatment

Increased fibroblast activation protein expression is positively correlated with the dedifferentiation and aggressiveness of thyroid cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with radioactive iodine refractory thyroid cancer and disease progression after first-line treatment. However, a major problem in the therapeutic use of 177Lu-DOTA-FAPI has been its short half-life and fast rate of clearance. This study was designed to evaluate the safety, tolerability, and maximum tolerated dose of a long-lasting radiolabeled fibroblast activation protein inhibitor 177Lu-DOTA-EB-FAPI in mRAIR-TC patients with PD after TKIs treatment.

Read the detailed description

This dose-escalation study will include a maximum of 20 mRAIR-TC subjects with progressive disease after tyrosine kinases inhibitors (TKIs) treatment, with an increased radiotracer uptake in tumors on 68Ga-FAPI-46 PET/CT. The initial dose of 177Lu-DOTA-EB-FAPI is 2.22GBq (60 mCi), and subsequent cohorts receive an incremental 50% dose increase until dose-limiting toxicity (DLT) was observed. Treatment is planned for up to 2 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the safety and maximum tolerated dose of 177Lu-DOTA-EB-FAPI used for radioligand therapy in patients with advanced mRAIR-TC. Secondary endpoints included dosimetry and determination of the preliminary treatment efficacy of 177Lu-DOTA-EB-FAPI.

Being tested
177Lu-DOTA-EB-FAPI 1 radionuclide therapy, 177Lu-DOTA-EB-FAPI 2 radionuclide therapy, 177Lu-DOTA-EB-FAPI 3 radionuclide therapy
Keywords
radioactive iodine refractory thyroid cancer, RAIR-TC, radioligand therapy, 177Lu-DOTA-EB-FAPI
Medical subject headings
Thyroid Neoplasms, Thyroid Cancer, Papillary, Adenocarcinoma, Follicular, Thyroid cancer, Hurthle cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-DOTA-EB-FAPI 1 radionuclide therapyDrug

    radionuclide therapy using 177Lu-DOTA-EB-FAPI 60 mCi (2.22 GBq) will be performed 6-weekly. A maximum of 2 cycles will be administered.

  • 177Lu-DOTA-EB-FAPI 2 radionuclide therapyDrug

    radionuclide therapy using 177Lu-DOTA-EB-FAPI 90 mCi (3.33 GBq) will be performed 6-weekly. A maximum of 2 cycles will be administered.

  • 177Lu-DOTA-EB-FAPI 3 radionuclide therapyDrug

    radionuclide therapy using 177Lu-DOTA-EB-FAPI 135 mCi (4.99 GBq) will be performed 6-weekly. A maximum of 2 cycles will be administered.

Study groups in NCT05410821
Study groupRoleWhat they receive
177Lu-DOTA-EB-FAPI 1Experimental177Lu-DOTA-EB-FAPI A maximum of 2 cycles of 60 mCi (2.22 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 2 cycles, every 6 weeks
Receives: Drug: 177Lu-DOTA-EB-FAPI 1 radionuclide therapy
177Lu-DOTA-EB-FAPI 2Experimental177Lu-DOTA-EB-FAPI A maximum of 2 cycles of 90mCi (3.33 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 2 cycles, every 6 weeks
Receives: Drug: 177Lu-DOTA-EB-FAPI 2 radionuclide therapy
177Lu-DOTA-EB-FAPI 3Experimental177Lu-DOTA-EB-FAPI A maximum of 2 cycles of 135 mCi (4.99 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 2 cycles, every 6 weeks
Receives: Drug: 177Lu-DOTA-EB-FAPI 3 radionuclide therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-related adverse events (safety and tolerability)

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Dose-limiting toxicity was defined as any 177Lu-DOTA-EB-FAPI-related AE ≥ grade 3 (G3).

    Measured: From date of involvement until 6 weeks after the second treatment cycles

  2. To determine the maximum tolerated dose (MTD)

    The MTD is the dose level below that which 2 out of 6 subjects in a cohort have DLT

    Measured: From date of involvement until 6 weeks after the second treatment cycles

Secondary outcomes (2)

  1. Objective response rate (ORR)

    68Ga-Fibroblast activation protein inhibitor 46 will be performed for efficacy evaluation by RECIST 1.1. Particularly, 68Ga-FAPI-46 will be performed at baseline, and 6 weeks after each treatment cycle.

    Measured: baseline, 6 weeks after each treatment cycle

  2. Dosimetry

    Dosimetry, measured as absorbed dose in tumor and normal organs (Gy/GBq), was estimated in the first treatment cycle for each patient.

    Measured: Dosimetry was estimated in the first treatment cycle for each patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start15 Jun 2022
  3. Primary completion15 Jun 2024
  4. Study completion27 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
classic 3+3 dose escalation
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05410821
Sponsor's protocol ID
XMYY-2022KY054
Status last verified
Mar 2025
First submitted
5 Jun 2022
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 177Lu-DOTA-EB-FAPI 1 radionuclide therapy, 177Lu-DOTA-EB-FAPI 2 radionuclide therapy and 177Lu-DOTA-EB-FAPI 3 radionuclide therapy in people with Refractory Thyroid Gland Carcinoma and Refractory Thyroid Gland Papillary Carcinoma, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related adverse events (safety and tolerability) (time frame: From date of involvement until 6 weeks after the second treatment cycles). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05410821.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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