Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05723640
Study type Interventional
Source Yantai LNC Biotechnology Singapore PTE. LTD.
Contact Wei Peng Yong, Dr.
Phone 6908 2222
Email Wei_Peng_YONG@nuhs.edu.sg
Status Recruiting
Phase Phase 1
Start date October 3, 2023
Completion date March 30, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03628677 - A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies Phase 1
Completed NCT04976803 - Tissue Collection for Correlation Between ATM Alterations by Next-Generation Sequencing and ATM Loss-of-Protein
Recruiting NCT04932525 - Gustave Roussy Cancer Profiling Phase 1
Recruiting NCT04643418 - Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04443088 - An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors Phase 1
Recruiting NCT04942717 - Adapting for Latinx Populations an Intervention That Involves Discussing and Sharing Patients' Health-Related Values
Recruiting NCT04169321 - Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors Phase 1
Recruiting NCT05695638 - Proseq Cancer: Genomic Profiling in Patients With Incurable Cancer in Search for Targeted Treatment
Completed NCT03318445 - Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair Phase 1
Recruiting NCT04537936 - Psychotherapy Intervention for Latinos With Adv Cancer N/A
Completed NCT04252339 - RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors Phase 1
Active, not recruiting NCT04577963 - A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06136065 - 68 Gallium-Fibroblast Activating Protein Inhibitors-46 Positron Emission Tomography - Computerized Tomography for Molecular Assessment of Fibroblast Activation and Risk Assessment in Solid Tumors Phase 2
Recruiting NCT04015609 - Psychotherapy Intervention for Latinos With Advanced Cancer N/A
Available NCT04100694 - Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor