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

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Trial Identification

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

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)

Study ID: NCT05068141

Conditions

Triple Negative Breast Cancer

Interventions

SG001

Nab-paclitaxel

Study Description

Brief 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.

Detailed 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.