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The Safety and Dosimetry Study of 177Lu-LNC1003 Injection

NCT06237491 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-07-24

No results posted yet for this study

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

Conditions

  • Metastatic Castration-resistant Prostate Cancer, mCRPC

Interventions

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.

Sponsors & Collaborators

  • Yantai LNC Biotechnology Singapore PTE. LTD.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2025-11-07
Completion
2025-12-17
FDA Drug
Yes

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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 NCT06237491 on ClinicalTrials.gov