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A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer
Sponsor: Akeso
Summary
This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK117/AK112 administered with chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
Official title: A Phase II Study of AK117/AK112 in Combination With Chemotherapy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2022-03-23
Completion Date
2027-06-30
Last Updated
2026-03-16
Healthy Volunteers
No
Interventions
AK117
Intravenous (IV) infusion
AK112
Intravenous (IV) infusion
Nab paclitaxel
Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
paclitaxel
Paclitaxel at a starting dose of 90 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Locations (2)
Hunan Cancer Hospital
Changsha, China
Xiangyang Central Hospital
Xiangyang, China