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Clinical Trial Summary

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


Clinical Trial Description

This is an open, multicenter Phase Ib/II clinical trial of LBL-007 combined with Tislelizumab in the treatment of malignant tumors,which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness. The study was divided into two phases: Phase Ib (Part A): Dose escalation and PK expansion; Phase II includes: Part B, Part C, Part D, Part E, Part F, Part G, Part H. Part B ~ Part H will be designed and conducted based on the safety , tolerability and PK analysis of the Part A Study Part, after RP2D is determined, will be used for Part B ~ Part H cohort. Approximately 250-490 subjects will be enrolled (Specific sample size shall be subject to actual occurrence) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05516914
Study type Interventional
Source Nanjing Leads Biolabs Co.,Ltd
Contact Dongtao Meng
Phone 02583378099
Email mengdongtao@leadsbiolabs.com
Status Recruiting
Phase Phase 1/Phase 2
Start date September 1, 2022
Completion date June 30, 2025

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