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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)

NCT05068141 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2021-10-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SG001

Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 240 mg, i.v., q2w

DRUG

Nab-paclitaxel

Paclitaxel for Injection (Albumin Bound), 100 mg/m\^2, i.v., D1, D8, D15 of every 4-week cycle

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • herui yao · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  • wang ying · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-10-01
Completion
2023-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05068141 on ClinicalTrials.gov