NCT05723640

The Safety and Dosimetry Study of 177Lu-LNC1004 Injection

Phase I, Open-Label Study of the Safety and Dosimetry of a 4-Dose Regimen of Escalating Doses of 177Lu-LNC1004 Injection in Adult Patients With Advanced Fibroblast Activation Protein (FAP)-Positive Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Yantai LNC Biotechnology Singapore PTE. LTD. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Detailed description

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. 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, from 30 mCi to 100 mCi (1.11 - 3.7 GBq). This classic 3+3 design includes 3 patients for the first dose level group. If no DLT occurs, 3 patients will be enrolled at the next dose level. If a DLT occurs at a certain dose level, 3 additional patients will be enrolled at the previous dose level. The highest dose with no more than 1 DLT out of 6 patients will be defined as MTD. If there is no MTD observed after the dose escalation up to 100 mCi, a comprehensive evaluation should be made by investigator and sponsor to determine whether an escalation to a higher dose can be conducted or not based on the known safety, radiation dose and efficacy characteristics.

Conditions

• Solid Tumor, Unspecified, Adult

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-03
• Primary completion: 2024-09-25
• Completion: 2024-09-25
• First posted: 2023-02-13
• Last updated: 2025-09-08

Locations

1 site across 1 country: Singapore

Regulatory

• FDA-regulated drug study