NCT06237491

The Safety and Dosimetry Study of 177Lu-LNC1003 Injection

Phase I, Open-Label Study of the Safety and Dosimetry of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in Adult Patients With Prostate Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Yantai LNC Biotechnology Singapore PTE. LTD. · Industry
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This proposal is a phase I, open-label study of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in patients with PSMA-positive mCRPC. In the clinical development, we aim to demonstrate the following: 1. Determination of the therapeutic dose(s) to be used in the expansion phase. 2. Demonstration of the safety and tolerability of 177Lu-LNC1003 at therapeutic doses. The treatment regimen will consist of a single-dose intravenous administration of 177Lu-LNC1003 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 3 different dose levels

Detailed description

This proposal is a phase I, open-label study of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in patients with PSMA-positive mCRPC. The treatment regimen will consist of a single-dose intravenous administration of 177Lu-LNC1003 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 3 different dose levels, from 30 mCi to 70 mCi (1.11 GBq - 2.59 GBq). This classic "3+3" design recruits 3 patients for the first dose level group. If no dose limiting toxicity (DLT) occurs in the first cycle, then 3 new patients will enter the next higher dose level. If any DLT occurs at a certain dose level, 3 additional patients will be enrolled at this current dose level (in total 6 patients now) to be assessed. The highest dose level(s) at which less than one-third of patients (e.g., 0 of 3 or 1 of 6 patients) experience a DLT will be declared the maximum tolerated dose (MTD). If there is no MTD observed after the dose escalation up to 70 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 data, radiation doses for similar drugs documented in literature and treatment responses at the doses administered.

Conditions

• Metastatic Castration-resistant Prostate Cancer, mCRPC

Interventions

Type	Name	Description
DRUG	177Lu-LNC1003 Injection group 1	The treatment regimen will consist of a single dose 30 mCi 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-LNC1003 Injection group 2	The treatment regimen will consist of a single dose 50 mCi 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-LNC1003 Injection group 3	The treatment regimen will consist of a single dose 70 mCi 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: 2025-05-07
• Primary completion: 2025-11-07
• Completion: 2025-12-17
• First posted: 2024-02-01
• Last updated: 2024-07-24

Regulatory

• FDA-regulated drug study