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The Safety and Dosimetry Study of 177Lu-LNC1004 Injection

NCT05723640 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-09-08

No results posted yet for this study

Summary

This proposal is a phase I, open-label study of a 4-Dose Regimen of Escalating Doses of 177Lu-LNC1004 Injection in patients with recurrent or metastatic, fibroblast activation protein-positive solid tumors.

In the clinical development, we aim to demonstrate the following:

* 177Lu-LNC1004 Injection is safe and tolerable at therapeutic dose.
* Determination of dose(s) to be used in the expansion phase. The treatment regimen will consist of a single dose intravenous administration of 177Lu-LNC1004 Injection per 6-week cycle, for a total of 2 cycles. The dose per cycle will be fixed for each patient and will be escalated in 4 different dose levels

Conditions

  • Solid Tumor, Unspecified, Adult

Interventions

DRUG

177Lu-LNC1004 Injection group 1 radionuclide therapy

The treatment regimen will consist of a single dose 30mCi intravenous administration of 177Lu-LNC1004 Injection per 6-week cycle, for a total of 2 cycles, the dose per cycle will be fixed.

DRUG

177Lu-LNC1004 Injection group 2 radionuclide therapy

The treatment regimen will consist of a single dose 60mCi intravenous administration of 177Lu-LNC1004 Injection per 6-week cycle, for a total of 2 cycles, the dose per cycle will be fixed.

DRUG

177Lu-LNC1004 Injection group 3 radionuclide therapy

The treatment regimen will consist of a single dose 80mCi intravenous administration of 177Lu-LNC1004 Injection per 6-week cycle, for a total of 2 cycles, the dose per cycle will be fixed.

DRUG

177Lu-LNC1004 Injection group 4 radionuclide therapy

The treatment regimen will consist of a single dose 100mCi intravenous administration of 177Lu-LNC1004 Injection per 6-week cycle, for a total of 2 cycles, the dose per cycle will be fixed.

Sponsors & Collaborators

  • Yantai LNC Biotechnology Singapore PTE. LTD.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2024-09-25
Completion
2024-09-25
FDA Drug
Yes

Countries

  • Singapore

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 NCT05723640 on ClinicalTrials.gov