NCT03908814

Phase I Clinical Trial of Human Anti-PD-L1 Antibody Injection (LDP) in Patients With Advanced Malignant Tumors

Phase I Clinical Trial to Evaluate the Safety, Tolerance and Pharmacokinetics of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) in Patients With Advanced Malignant Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Dragonboat Biopharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of LDP in subjects with advanced malignant tumors.

Detailed description

This trial is an open, dose escalation phase I clinical trial study of patients with advanced cancer who have failed standard treatment. The trial is divided into a dose escalation phase and an expansion phase. Approximately 130 patients will be enrolled in this trial. The dose-increasing phase is about 30 cases, and the expansion stage is about 100 cases.

Conditions

• Advanced Tumors

Interventions

Type	Name	Description
DRUG	Whole Human Anti-PD-L1 Antibody Injection (LDP)	Dose escalation study evaluating six dose levels (0.1, 0.3, 1, 3 , 10and 20 mg/kg) of LDP.

Timeline

• Start date: 2019-04-27
• Primary completion: 2021-11-26
• Completion: 2022-04-26
• First posted: 2019-04-09
• Last updated: 2019-10-31

Locations

1 site across 1 country: China