Advanced thyroid cancer
Conditions
Interventions
177Lu-FAPI-RGD Treatment Group:177Lu-LNC1009 injection (sequential dose cohorts: starting with 60 mCi, with subsequent possible exploration of 80 mCi)
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Able to understand and voluntarily sign the written Informed Consent Form (ICF); 2. Aged >=18 years, regardless of sex; 3. Histologically or cytologically confirmed differentiated thyroid carcinoma, including papillary thyroid carcinoma, follicular thyroid carcinoma, or their variants; 4. Meets the definition of radioactive iodine-refractory differentiated thyroid carcinoma (RAIR-DTC), defined by either of the following conditions: (1) The lesion does not demonstrate radioactive iodine uptake during radioactive iodine therapy; (2) The lesion demonstrates radioactive iodine uptake, but the disease continues to progress; 5. Patients with RAIR-DTC who have previously received at least one tyrosine kinase inhibitor (TKI) and experienced disease progression. A limited number of first-line patients who have not received prior systemic therapy may be enrolled for exploratory observation if deemed appropriate by the investigator; 6. Presence of radiologically evaluable lesions according to RECIST version 1.1; 7. Abnormal uptake in the lesion confirmed by FAP-integrin avß3-targeted PET/CT imaging, such as^68Ga/^18F-LNC1007, with SUVmax higher than that of normal liver tissue and physiological uptake excluded; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1; 9. Estimated life expectancy of >=6 months; 10. Adequate organ function, defined as follows: (1) Bone marrow function: absolute neutrophil count >=1.5 × 10^9/L, platelet count >=100 × 10^9/L, and hemoglobin >=100 g/L; (2) Liver function: albumin >=30 g/L, total bilirubin =50 mL/min, calculated using the Cockcroft-Gault formula; 11. Toxicities related to prior antitumor therapy have recovered to Grade 0 or 1 according to CTCAE version 5.0, except for: (a) alopecia; (b) hyperpigmentation; (c) late radiation-induced toxicities that are judged by the investigator to be irreversible; 12. For subjects who have previously received tyrosine kinase inhibitors (TKIs) or other systemic therapies, an appropriate washout period must be completed before the first dose, generally defined as 5 half-lives or 4 weeks, whichever is shorter; 13. Agrees to follow radiation safety precautions as instructed by the investigator during the study period.
Exclusion criteria
Exclusion criteria: 1. Presence of uncontrolled or symptomatic central nervous system metastases, such as brain metastases or leptomeningeal metastases; 2. Prior radioligand therapy targeting FAP or integrin avß3 within 6 weeks before enrollment; 3. Prior treatment with other systemic radionuclide therapies, such as radium-223, strontium-89, or samarium-153, within 6 months before administration of the investigational drug; 4. History of severe bone marrow suppression, such as Grade >=3 hematologic toxicity with prolonged recovery, or inadequate bone marrow reserve as judged by the investigator; 5. Presence of uncontrolled severe comorbidities, including but not limited to: (1) severe cardiovascular diseases, such as unstable angina, heart failure, or severe arrhythmia; (2) uncontrolled infection; (3) significant hepatic, renal, or other major organ dysfunction; 6. Presence of massive pleural effusion, ascites, or other conditions that may interfere with study assessment; 7. Inability to tolerate imaging examinations such as PET/CT or SPECT/CT; 8. Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period and within 6 months after administration of the investigational drug; 9. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study, such as poor compliance; 10. Known hypersensitivity or delayed allergic reaction to any component of^177Lu-LNC1009 injection or similar agents; 11. Any other uncontrolled disease, psychiatric condition, or surgical condition that may interfere with completion of the study, including poor compliance, or that may make the subject unsuitable for treatment with the investigational product, or any other condition that the investigator considers inappropriate for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Overall Response(BOR);Duration of Response (DOR);Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related Adverse Events (TRAEs);Disease Control Rate (DCR);Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactLin Yansong
Peking Union Medical College Hospital
Outcome results
None listed