Evaluating AK117/AK112 for advanced 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
This study is testing if a new combination of drugs, AK117 and AK112, can help people with advanced triple-negative breast cancer when used with chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Akeso Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Changsha and 1 other locations) |
| Trial ID | NCT05227664 on ClinicalTrials.gov |
What this trial studies
This Phase II trial aims to assess the efficacy, safety, and pharmacokinetics of AK117 and AK112 when combined with chemotherapy in patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not previously received systemic therapy for their condition. Participants will receive either Nab paclitaxel or paclitaxel alongside the investigational drugs. The study will focus on patients with documented TNBC characterized by the absence of HER2, ER, and PR expression.
Who should consider this trial
Good fit: Ideal candidates are individuals with metastatic or locally advanced TNBC who have not undergone prior chemotherapy or targeted therapy.
Not a fit: Patients with known central nervous system disease or those who have received prior systemic therapy for their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced triple-negative breast cancer.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in treating triple-negative breast cancer with novel agents.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Changsha and 1 other locations
- Hunan Cancer Hospital — Changsha, China (Recruiting)
- Xiangyang Central Hospital — Xiangyang, China (Recruiting)
Study contacts
- Study coordinator: Xufang Yu, MD
- Email: clincialtrails@akesobio.com
- Phone: +86(0760)89873999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.