Solid Tumor, Unspecified, Adult Clinical Trial
Official title:
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
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
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. ;
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