NCT05170958

A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: Nanjing Leads Biolabs Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors

Detailed description

This trial is a single-arm, open-label, phase I/II clinical study of LBL-024 in patients with advanced malignant tumors. The phase I dose escalation and PK expansion phase plans to include patients with advanced malignant tumors who have failed previous standard treatment or do not have standard treatment or are not applicable to standard treatment at this stage. The phase IIa indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity and preliminary efficacy. Single-arm registry clinical study to be conducted in Phase IIb. This trial includes two parts: Part I: A Phase I/IIa clinical study on the safety, tolerability, PK and efficacy of LBL-024 in patients with advanced malignant tumor. Part II:Phase IIb is a pivotal single-arm clinical study.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	LBL-024 for Injection	LBL-024 was given every three weeks for treatment

Timeline

• Start date: 2022-01-06
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-12-28
• Last updated: 2025-05-22

Locations

49 sites across 1 country: China