NCT05107011

Phase I/II Clinical Trial of LBL-015 for Injection

A Multicenter, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-015 in Patients With Advanced Malignant Tumors.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Nanjing Leads Biolabs Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Multicenter, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-015 in Patients With Advanced Malignant Tumors.

Detailed description

This study is a single-arm, open-label, multi-center, dose-escalation and expansion phase I/II study to evaluate the safety, tolerability, pharmacokinetic characteristics, receptor occupancy, immunogenicity and efficacy of LBL-015 in patients with advanced malignant tumors.About 202 patients with advanced malignant tumor will be enrolled. The study is divided into Phase I study stage (dose escalation/PK expansion stage) and Phase II study stage (indication expansion stage). Patients with advanced or metastatic advanced malignant tumor who have failed previous standard treatment, are not suitable for standard treatment or have no standard treatment are included in the phase I study. After obtaining the RP2D in Phase I study ,Phase II study stage (indication expansion stage) was initiated.

Conditions

• Advanced Malignant Tumor

Interventions

Type	Name	Description
DRUG	LBL-015 for Injections	Initial dose - MTD ; Q2W ; intravenous infusion

Timeline

• Start date: 2021-11-08
• Primary completion: 2023-12-05
• Completion: 2023-12-05
• First posted: 2021-11-04
• Last updated: 2024-10-28

Locations

6 sites across 1 country: China