Clinical trial · Interventional
Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer
Phase II Study of Efficacy and Safety Evaluation of KN026 Monotherapy or Combination Therapy in Patients With HER2 Expressing or Positive Metastatic Breast Cancer
NCT04165993CI-TRIAL-00069803unknownPhase 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 is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent chemotherapy and KN026 | Drug | — | UNRESOLVED |
| KN026 combination | Drug | — | UNRESOLVED |
| KN026 monotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Concurrent chemotherapy and KN026
- description
- KN026 combined with docetaxol
- interventionNames
- Drug: Concurrent chemotherapy and KN026
- type
- EXPERIMENTAL
- label
- KN026 monotherapy
- description
- KN026 monotherapy
- interventionNames
- Drug: KN026 monotherapy
- type
- EXPERIMENTAL
- label
- A combination treatment of KN026 and KN046
- description
- KN026 combined with KN046
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female subject \>= 18 years * Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer * ECOG score 0 or 1 * Life expectancy \>3 months * According to the definition of RECIST1.1, the patient has at least one measurable lesion * Adequate organ function prior to start treatment with KN026 * Able to understand, voluntarily participate and willing to sign the ICF Exclusion Criteria: * Accepted any other anti-tumor drug therapies within 4 weeks before fist dose * Accepted radiotherapy within 4 weeks before enrollment * Subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible * Pregnant or nursing females;or intend pregnancy within this study period or within 6 monthes after the end of this study * History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation * History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation * Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
References
Publications (0)
Data not yet available
No reference posted for this study.