NCT04750382

A Study of HX008 for the Treatment of Patients With Metastatic Triple Negative Breast Cancer

A Single-armed Multicenter Phase Ib / II Study of HX008 (a Recombinant Humanized Anti-PD-1 Monoclonal Antibody) Combined With GP Regimen as the First-line Treatment in Patients With Metastatic Triple Negative Breast Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Taizhou Hanzhong biomedical co. LTD · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

HX008 is a humanized monoclonal antibody targeting PD-1 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 and preliminary efficacy of HX008+cisplatin+gemcitabine for the treatment of patients with metastatic triple-negative breast cancer will be evaluated.

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	HX008+Cisplatin+Gemcitabine	Participants will receive HX008 3mg/kg, Day 1,Q3W for up to 2 years + Cisplatin 75mg/m\^2, Day 1, Q3W for up to 6 cycles +Gemcitabine 1250mg/m\^2, Day 1, Day 8, Q3W for up to 6 cycles

Timeline

• Start date: 2019-07-15
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2021-02-11
• Last updated: 2021-02-11

Locations

1 site across 1 country: China