Clinical trial · Interventional
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
NCT05227664CI-TRIAL-00105565active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK112 | Drug | — | UNRESOLVED |
| AK117 | Drug | — | UNRESOLVED |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)
- description
- Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
- interventionNames
- Drug: AK117
- Drug: AK112
- Drug: Nab paclitaxel
- Drug: paclitaxel
- type
- EXPERIMENTAL
- label
- cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)
- description
- Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
- interventionNames
- Drug: AK117
- Drug: Nab paclitaxel
- Drug: paclitaxel
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDShao X, Tian C, Chen Z, Huang J, Wang Y, Sun T, Yi T, Wu Y, Sun W, Yu X, Wang ZM, Li B, Xia Y, Wang X, Ouyang Q. First-line PD-1/VEGF bispecific antibody plus chemotherapy in triple-negative breast cancer: a phase 2 trial. Nat Med. 2026 Aug 12. doi: 10.1038/s41591-026-04564-7. Online ahead of print. PMID 42587052