A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors

Advanced Malignant Tumors Clinical Trial

Official title: A Multicenter, Open Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-033 in the Treatment of Patients With Advanced Malignant Tumors.

Status Recruiting

Clinical Trial Summary

This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

Clinical Trial Description

This is an open, multicenter Phase I/II clinical trial of LBL-033 in the treatment of patients with advanced malignant tumors，which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

The trial is divided into 2 parts: Phase 1 and Phase 2

Phase I study:

Dose-escalation and PK expansion.The PK expansion study will be judged on the basis of dose escalation data.

Phase II study:

Dose expansion included 4 cohorts that required patients with MUC16-positive malignancies.Blood samples will be collected from all subjects in this trial.

Phase I and Phase II studies are expected to recruit 113-468 patients ;

Related Conditions & MeSH terms

• Advanced Malignant Tumors
• Neoplasms

• NCT number: NCT05779163
• Study type: Interventional
• Source: Nanjing Leads Biolabs Co.,Ltd
• Contact: xue kong
• Phone: 025-83378099-842
• Email: kongxue@leadsbiolabs.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 14, 2023
• Completion date: March 31, 2026