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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Intravenous (IV) infusion
Intravenous (IV) infusion
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.
Hunan Cancer Hospital
Changsha, China
RECRUITINGXiangyang Central Hospital
Xiangyang, China
RECRUITINGObjective response rates (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1
Time frame: Up to approximately 2 years
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Disease control rate (DCR) is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST V1.1
Time frame: Up to approximately 2 years
Duration of response (DOR)
DOR is defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first
Time frame: Up to approximately 2 years
Time to response (TTR)
TTR is defined for participants who had an objective response as the time from the start of treatment to the first occurrence of a documented unconfirmed response (CR or PR) .
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Time frame: Up to approximately 2 years
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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.
Overall survival (OS)
Overall survival is defined as the time from the start of treatment until death due to any cause.
Time frame: Up to approximately 2 years