NCT05516914

A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors

A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Tislelizumab in the Treatment of Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Nanjing Leads Biolabs Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Malignant Tumors

Interventions

Type	Name	Description
DRUG	LBL-007 Injection	Initial dose - MTD; Q3W; intravenous infusion
DRUG	Tislelizumab Injection	Initial dose; Q3W; intravenous infusion
DRUG	Cisplatin Injection	Initial dose；Q3W; intravenous infusion
DRUG	Gemcitabine Hydrochloride for Injection	Initial dose；Q3W; intravenous infusion
DRUG	Docetaxel injection	Initial dose；Q3W; intravenous infusion

Timeline

• Start date: 2022-09-01
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2022-08-26
• Last updated: 2026-04-01

Locations

15 sites across 1 country: China