OncoMatch/Clinical Trials/NCT06898437
Study of 177Lu-LNC1004 Injection in FAP-positive Radioiodine-refractory Differentiated Thyroid Cancer
Is NCT06898437 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies 177Lu-LNC1004 for radioiodine refractory differentiated thyroid cancer.
Treatment: 177Lu-LNC1004 — 177Lu-LNC1004 Injection, a radiopharmaceutical targeting FAP, has demonstrated preliminary antitumor effect in advanced FAP-positive solid tumor patients. The primary purpose of this study is to evaluate the efficacy of 177Lu-LNC1004 Injection in patients with FAP-positive RAIR-DTC who have failed first-line TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: FAP overexpression (FAP-positive lesion confirmed by FAPI PET/CT scan)
FAP-positive lesion confirmed by FAPI PET/CT scan
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: tyrosine kinase inhibitor
subject who has failed TKIs treatment or refuse standard therapy
Cannot have received: chemotherapy
Exception: within 4 weeks prior to first dosing
Received antitumor treatment including chemotherapy, radiotherapy, immunotherapy, and traditional Chinese medicine, etc. within 4 weeks prior to first dosing.
Cannot have received: radiotherapy
Exception: within 4 weeks prior to first dosing
Received antitumor treatment including chemotherapy, radiotherapy, immunotherapy, and traditional Chinese medicine, etc. within 4 weeks prior to first dosing.
Cannot have received: immunotherapy
Exception: within 4 weeks prior to first dosing
Received antitumor treatment including chemotherapy, radiotherapy, immunotherapy, and traditional Chinese medicine, etc. within 4 weeks prior to first dosing.
Cannot have received: targeted therapy
Exception: discontinued treatment for less than 4 weeks or 10 half-lives prior to first dosing
Subject who previously received targeted therapy, but discontinued treatment for less than 4 weeks or 10 half-lives prior to first dosing.
Cannot have received: systemic radionuclide therapy
Exception: within 6 months before first dosing
Received systemic radionuclide therapy or radioembolization within 6 months before first dosing
Cannot have received: radioembolization
Exception: within 6 months before first dosing
Received systemic radionuclide therapy or radioembolization within 6 months before first dosing
Cannot have received: external beam radiotherapy
Exception: within 2 weeks before the first dosing
any external beam radiotherapy within 2 weeks before the first dosing
Lab requirements
Blood counts
hemoglobin ≥ 100 g/L, neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L
Kidney function
creatinine clearance ≥ 60 mL/min
Liver function
albumin ≥ 3.0 g/dL; total bilirubin ≤ 1.5 × ULN; ALT and AST < 3 × ULN without liver metastasis or < 5 × ULN with liver metastasis
Cardiac function
NYHA grade ≥ 3, serious heart rhythm or conduction abnormalities, QTcF > 470 ms in male and > 480 ms in female, aortic dissection, stroke, or other grade 3 or higher cardiovascular/cerebrovascular event within 6 months
Adequate organ function as defined by: Bone marrow function: hemoglobin ≥ 100 g/L, neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L; Liver function: albumin ≥ 3.0 g/dL; total bilirubin ≤ 1.5 × ULN; ALT and AST < 3 × ULN without liver metastasis or < 5 × ULN with liver metastasis; Renal function: creatinine clearance ≥ 60 mL/min. Cardiac: NYHA grade ≥ 3, serious heart rhythm or conduction abnormalities, QTcF > 470 ms in male and > 480 ms in female, aortic dissection, stroke, or other grade 3 or higher cardiovascular/cerebrovascular event within 6 months [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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