Metastatic Triple-negative Breast Cancer, Locally Advanced Triple-negative Breast Cancer
Conditions
Brief 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).
Interventions
DRUGAK117
Intravenous (IV) infusion
DRUGAK112
Intravenous (IV) infusion
DRUGNab 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.
DRUGpaclitaxel
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.
Sponsors
Akeso
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression * No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC * Eligible for taxane monotherapy * A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 5 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. * Eastern Cooperative Oncology Group performance status of 0 or 1 * Measurable disease as defined by RECIST v1.1 * Adequate hematologic and end-organ function
Exclusion criteria
* Known central nervous system (CNS) disease, except for asymptomatic CNS metastases * Leptomeningeal disease * Pregnancy or lactation * History of autoimmune disease * Prior allogeneic stem cell or solid organ transplantation * Positive test for human immunodeficiency virus * Active hepatitis B or hepatitis C * Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rates (ORR) | Up to approximately 2 years | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1 |
| Number of participants with adverse events (AEs) | Up to approximately 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | Up to approximately 2 years | Disease control rate (DCR) is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST V1.1 |
| Duration of response (DOR) | Up to approximately 2 years | 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 to response (TTR) | Up to approximately 2 years | 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) . |
| Progression-free survival (PFS) | Up to approximately 2 years | 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). |
| Overall survival (OS) | Up to approximately 2 years | Overall survival is defined as the time from the start of treatment until death due to any cause. |
Countries
China
Outcome results
None listed