OncoMatch/Clinical Trials/NCT06898437
Study of 177Lu-LNC1004 Injection in FAP-positive Radioiodine-refractory Differentiated Thyroid Cancer
Is NCT06898437 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Radioligand therapy
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)
Demographics
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.
Frequently asked questions
Is NCT06898437 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, radiotherapy, immunotherapy disqualifies patients from enrollment.
Does this trial require FAP?
Yes, FAP overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 85 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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