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

NCT04750382 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-02-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Taizhou Hanzhong biomedical co. LTD

    lead INDUSTRY

Principal Investigators

  • Xichun Hu · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2020-12-01
Completion
2021-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04750382 on ClinicalTrials.gov