NCT04756934

A Study of HX008 Plus LP002 for the Treatment of Patients With Advanced Melanoma

A Phase I Study of Tolerance and Pharmacokinetics of HX008 (a Humanized Monoclonal Antibody Targeting PD-1) Plus LP002 (a Humanized Monoclonal Antibody Targeting PD-L1) in Patients With Locally Advanced or Metastatic Melanoma Who Have Experienced Progressed Disease in Previous Anti-PD-1 or PD-L1 Therapy.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Taizhou HoudeAoke Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The subsequent treatment choices for the patients with advanced melanoma, who have failed the immune checkpoint inhibitor therapy of single agent. Evidences showed that PD-1 and PD-L1 signalling pathways are not redundant. Blocking both of them could produce synergistic effect. HX008 and LP002 are humanized monoclonal antibodies targeting PD-1 on T cells and PD-L1 on tumor cells respectively. In this study, participants with locally advanced or metastatic melanoma who have failed previous anti-PD-1 or PD-L1 will be administrated with HX008 plus LP002. The safety and preliminary efficacy will be evaluated.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	HX008	HX008: 200mg, Q3W
DRUG	LP002	LP002: 1mg/kg, or 3mg/kg, or 5mg/kg, Q3W

Timeline

• Start date: 2020-08-20
• Primary completion: 2021-08-20
• Completion: 2022-08-20
• First posted: 2021-02-16
• Last updated: 2021-02-16

Locations

1 site across 1 country: China