Last reviewed · How we verify
NCT05410821
Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Metastatic Radioactive Iodine Refractory Thyroid Cancer
Phase 1 trial testing 177Lu-DOTA-EB-FAPI 1 radionuclide therapy in Refractory Thyroid Gland Carcinoma in 12 participants. Completed in 27 March 2025.
15 June 2024
Quick facts
| Lead sponsor | The First Affiliated Hospital of Xiamen University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 15 June 2022 |
| Primary completion | 15 June 2024 |
| Estimated completion | 27 March 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- 177Lu-DOTA-EB-FAPI 1 radionuclide therapy — full drug profile →
- 177Lu-DOTA-EB-FAPI 2 radionuclide therapy — full drug profile →
- 177Lu-DOTA-EB-FAPI 3 radionuclide therapy — full drug profile →
Conditions studied
- Refractory Thyroid Gland Carcinoma — all drugs for Refractory Thyroid Gland Carcinoma →
- Refractory Thyroid Gland Papillary Carcinoma — all drugs for Refractory Thyroid Gland Papillary Carcinoma →
- Refractory Thyroid Gland Follicular Carcinoma — all drugs for Refractory Thyroid Gland Follicular Carcinoma →
- Refractory Thyroid Gland Hurthle Cell Carcinoma — all drugs for Refractory Thyroid Gland Hurthle Cell Carcinoma →
Sponsor
The First Affiliated Hospital of Xiamen University
Who can join
18 and older, any sex, with Refractory Thyroid Gland Carcinoma or Refractory Thyroid Gland Papillary Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Fibroblast activation protein-targeted radionuclide therapy: background, opportunities, and challenges of first (pre)clinical studies.
Privé BM, Boussihmad MA, Timmermans B, van Gemert WA, et al · · 2023 · cited 139× · PMID 36813980 · DOI 10.1007/s00259-023-06144-0 -
Fibroblast Activation Protein-Targeted Radioligand Therapy with 177Lu-EB-FAPI for Metastatic Radioiodine-Refractory Thyroid Cancer: First-in-Human, Dose-Escalation Study.
Fu H, Huang J, Zhao T, Wang H, et al · · 2023 · cited 67× · PMID 37801296 · DOI 10.1158/1078-0432.ccr-23-1983 -
Cancer-associated fibroblasts as therapeutic targets for cancer: advances, challenges, and future prospects.
Cao Z, Quazi S, Arora S, Osellame LD, et al · · 2025 · cited 57× · PMID 39780187 · DOI 10.1186/s12929-024-01099-2 -
Advances in targeting tumor microenvironment for immunotherapy.
Wang L, Zhang L, Zhang Z, Wu P, et al · · 2024 · cited 34× · PMID 39421736 · DOI 10.3389/fimmu.2024.1472772 -
A Primer on Radiopharmaceutical Therapy.
Salerno KE, Roy S, Ribaudo C, Fisher T, et al · · 2023 · cited 25× · PMID 35970373 · DOI 10.1016/j.ijrobp.2022.08.010 -
From basic research to clinical application: targeting fibroblast activation protein for cancer diagnosis and treatment.
Zhang Z, Tao J, Qiu J, Cao Z, et al · · 2024 · cited 21× · PMID 37726505 · DOI 10.1007/s13402-023-00872-z -
Therapeutic potential of FAPI RLT in oncology: A systematic review.
Ruzzeh S, Abdlkadir AS, Paez D, Kang KW, et al · · 2025 · cited 18× · PMID 40213678 · DOI 10.7150/thno.106108 -
Theranostics in targeting fibroblast activation protein bearing cells: Progress and challenges.
Rezaei S, Gharapapagh E, Dabiri S, Heidari P, et al · · 2023 · cited 17× · PMID 37481033 · DOI 10.1016/j.lfs.2023.121970
Verify or expand the search:
- PubMed search for NCT05410821
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Refractory Thyroid Gland Carcinoma
Currently open trials in the same condition.
- NCT04061980 — Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V · Phase 2 · active not recruiting
- NCT04284774 — Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a · Phase 2 · active not recruiting
- NCT03914300 — Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Can · Phase 2 · active not recruiting
- NCT02152995 — Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer · Phase 2 · active not recruiting
Other The First Affiliated Hospital of Xiamen University trials
Trials by the same sponsor.
- NCT06875063 — GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL · Phase 1 · recruiting
- NCT07486492 — Using Healthy Gut Bacteria to Boost Immune Treatment for Advanced Bowel Cancer · EARLY_PHASE1 · not yet recruiting
- NCT07458906 — DLL3-Targeted PET/CT in Neuroendocrine Carcinoma · NA · recruiting
- NCT07137052 — Precise Guidance of Adaptive Radiotherapy for Nasopharyngeal Carcinomar · not yet recruiting
- NCT07189884 — Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05410821 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Xiamen University
- Last refreshed: 1 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05410821.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing