Triple-Negative Breast Cancer (TNBC)
Conditions
Brief summary
This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).
Interventions
DRUGAK112
AK112 via intravenous (IV) infusion
DRUGNab-paclitaxel
Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
DRUGPlacebo
Placebo via IV infusion
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign a written informed consent form. 2. Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy of ≥ 3 months. 5. Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2. 6. Subjects who have not received prior systemic treatment for advanced breast cancer are eligible for the study. 7. Suitable for monotherapy with taxane-based agents. 8. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 9. Adequate organ function.
Exclusion criteria
1. Patients with locally recurrent disease who are eligible for surgery or radiotherapy. 2. History of other malignancies within the past 5 years. 3. Active autoimmune disease requiring systemic treatment within the past 2 years. 4. Pregnant or breastfeeding women. 5. Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study. 6. Participants with clinically symptomatic pleural effusion, pericardial effusion, or ascites that require repeated drainage. 7. Participants with a history of immune deficiency; those who test positive for HIV antibodies; those currently using systemic corticosteroids or other immunosuppressive agents on a long-term basis. 8. Individuals with known active tuberculosis (TB), or those suspected of having active TB (who must undergo clinical evaluation for exclusion), and those with known active syphilis infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by IRRC | Up to approximately 2 years | Progression-Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) |
| OS | Up to approximately 4 years | Overall survival (OS) is defined as the time from randomization to death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by investigator | Up to approximately 2 years | Progression-free survival is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first. |
| ORR assessed by IRRC or investigators | Up to approximately 2 years | Objective Response Rate (ORR) is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by IRRC or investigators based on RECIST 1.1 is presented. |
| DCR assessed by IRRC or investigators | Up to approximately 2 years | Disease control rate (DCR) is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by IRRC or investigators using RECIST v1.1 |
| DoR assessed by IRRC or investigators | Up to approximately 2 years | Duration of response (DoR) is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first. |
| TTR assessed by IRRC or investigators | Up to approximately 2 years | Time to response (TTR) is defined as the time to response based on RECIST v1.1. |
| Adverse Events (AEs) | Up to approximately 2 years | Incidence and severity of participants with adverse events |
| Cmax and Cmin | Up to approximately 2 years | AK112 serum drug concentrations in subjects at different time points after AK112 administration. |
| Anti-drug antibodies (ADA) | Up to approximately 2 years | Number of subjects with detectable anti-drug antibodies (ADA). |
Countries
China
Contacts
CONTACTXufang Yu
Outcome results
None listed