NCT04755543

A Study of LP002 for the Treatment of Patients With Malignant Digestive System Neoplasms

A Phase I Study of Safety and Pharmacokinetics of LP002 (a Humanized Monoclonal Antibody Targeting PD-L1) in Patients With Malignant Digestive System Neoplasms

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Taizhou HoudeAoke Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

LP002 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. In this study, the safety, pharmacokinetics and preliminary efficacy of LP002 for the treatment of malignant digestive system neoplasms will be evaluated.

Conditions

• Digestive System Neoplasms

Interventions

Type	Name	Description
DRUG	LP002	600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W).
DRUG	Cisplatin	50mg/m2 IV on Day 1, Q2W
DRUG	Fluorouracil	2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W
BIOLOGICAL	OH2 oncolytic virus	106 or 107 or 108 CCID50/mL by intra-tumoral injection, Q2W

Timeline

• Start date: 2019-06-17
• Primary completion: 2021-06-30
• Completion: 2022-06-30
• First posted: 2021-02-16
• Last updated: 2021-02-16

Locations

6 sites across 1 country: China