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A Study to Evaluate the Efficacy and Safety of SG001 in Combination With Nab-Paclitaxel in Patients With Advanced Triple-Negative Breast Cancer (TNBC)

Triple Negative Breast Cancer Clinical Trial

Official title:
A Single-arm, Open-label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of SG001 in Combination With Nab-Paclitaxel in Patients With Advanced Triple-Negative Breast Cancer (TNBC)

Clinical Trial Summary

This is a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of SG001 in combination with Nab-paclitaxel in patients with advanced TNBC.

Clinical Trial Description

This study is a single-arm, open label, multicenter phase II study to evaluate the efficacy and safety of SG001 in combination with nab-paclitaxel in patients with unresectable locally advanced, or recurrent, or metastatic TNBC. Eligible patients will receive SG001 intravenous infusion at a dose of 240 mg on Days 1 and 15 of every 4-week cycle and nab-paclitaxel intravenous infusion at a dose of 100 mg/m^2 on Days 1, 8, and 15 of every 4-week cycle until disease progression, or intolerable toxicity, or other discontinuation or termination criteria are met, for a maximum of 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05068141
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact beibei Zhai
Phone +86-021-60673937
Email zhaibeibei@mail.ecspc.com
Status Recruiting
Phase Phase 2
Start date October 1, 2021
Completion date October 1, 2023
View Details
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