Status:
RECRUITING
A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer
Lead Sponsor:
Akeso
Conditions:
Metastatic Triple-negative Breast Cancer
Locally Advanced Triple-negative Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05227664
Start Date
March 23 2022
End Date
December 30 2026
Last Update
March 12 2025
Active Locations (2)
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1
Hunan Cancer Hospital
Changsha, China
2
Xiangyang Central Hospital
Xiangyang, China