NCT05227664Active, not recruitingPhase 2
A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer
A Phase II Study of AK117/AK112 in Combination With Chemotherapy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 27 Jan 2022
- Start date
- 23 Mar 2022
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Akeso
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT05227664
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 23 Mar 2022 to the primary completion date, 30 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogeneic stem cell or solid organ transplantation
- Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment
Other illness
- Known central nervous system (CNS) disease, except for asymptomatic CNS metastases
- Leptomeningeal disease
- History of autoimmune disease
- Active hepatitis B or hepatitis C
Other
- Pregnancy or lactation
- Positive test for human immunodeficiency virus
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
Related publications
- First-line PD-1/VEGF bispecific antibody plus chemotherapy in triple-negative breast cancer: a phase 2 trial.Nat Med · 2026 · PMID 42587052
This page is information, not medical advice. Discuss any trial with your doctor.