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

NCT05410743 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

  • SSTR2-positive Tumors

Interventions

DRUG

177Lu-LNC1010 1

The patients were intravenously injected with single dose 2.22GBq (60 mCi) of 177Lu-LNC1010 and underwent 68Ga-DOTA-TATE PET/CT scans before and after the treatment.

DRUG

177Lu-LNC1010 2

The patients were intravenously injected with single dose 3.33GBq （90 mCi) of 177Lu-LNC1010 and underwent 68Ga-DOTA-TATE PET/CT scans before and after the treatment.

DRUG

177Lu-LNC1010 3

The patients were intravenously injected with single dose 4.99GBq (135 mCi) of 177Lu-LNC1010 and underwent 68Ga-DOTA-TATE PET/CT scans before and after the treatment.

DRUG

177Lu-LNC1010 4

Patients received a single, fixed dose of 177Lu-LNC1010 via intravenous injection, utilizing the well-tolerated and safe dose identified in Phase 1. They also underwent 68Ga-DOTA-TATE PET/CT scans both before and after the treatment to monitor their response.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05410743 on ClinicalTrials.gov