drugset / Trial / NCT05410743

Evaluation of 177Lu-TATE-EB-01(LNC1010)in SSTR2-positive Tumors

NCT05410743 ↗

Phase 1/2 Completed 30 enrolled The First Affiliated Hospital of Xiamen University
RandomizedParallel-groupOpen-labelTreatment

Summary

177Lu-LNC1010(177Lu-EB-TATE-01) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive tumors. In this study, we designed and developed a new radioligand, EB-TATE-01 (second generation long-acting EB-TATE formula), through combining EB and altering the linker to further improve the pharmacokinetics and pharmacodynamics, leading to substantially enhanced radioligand therapy effect. This is an open-label, non-controlled, non-randomized study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-LNC1010 in patients with advanced SSTR2-positive tumors. Different groups with doses of 2.22GBq (60 mCi), 3.33GBq (90mCi) and 4.99GBq (145mCi) of 177Lu-LNC1010 will be injected intravenously. All patients will undergo 68Ga-DOTA-Octreotide(TATE) PET/CT scans before and after the treatment.

Timeline

Start
2022-06-01
Primary completion
2025-03-24
Completion
2025-03-24

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-LNC1010 Peptide 2220 mbq Intravenous
Subject 177Lu-LNC1010 Peptide 3330 mbq Intravenous
Subject 177Lu-LNC1010 Peptide 4990 mbq Intravenous

Indications

No indication recorded.