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.
This prospective, single-arm, open label, single-center clinical trial is planned to enroll approximately 20 RAIR-DTC subjects s who have failed TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles. Disease progression and occurrence of AEs will be monitored during the trial. Based on tumor response assessment and AEs occurrence in the first 2 cycles, subjects may continue to receive 177Lu-LNC1004 Injection for a maximum of 6 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravenous administration: a single dose of 80 mCi per Cycle
Peking Union Medical College Hospital
Beijing, China
RECRUITINGOverall Response Rate (ORR)
ORR is defined as the the proportion of subjects who achieve a best overall response of Complete Response (CR) or Partial Response (PR).
Time frame: up to 24 months
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects who achieve a best overall response of CR, PR or Stable Disease (SD).
Time frame: up to 24 months
Duration of Response (DoR)
DoR is defined as the time from the earliest date of documented CR or PR until documented disease progression or death, whichever occurs first.
Time frame: up to 24 months
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of 177Lu-LNC1004 Injection to the date of documented disease progression or death, whichever occurs first.
Time frame: up to 24 months
Biochemical Response (BR)
BR is defined as the percentage of change in serum Thyroglobulin (Tg) from baseline.
Time frame: up to 24 months
Safety
Adverse Event (AE), Serious Adverse Event (SAE), Treatment related Adverse Event (TRAE).
Time frame: up to 24 months
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