Clinical trial · Interventional
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
KN035, a Single Domain PD-L1 Subcutanuous Injection Antibody, in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
- 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, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.
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 |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| KN035 | Biological | — | UNRESOLVED |
| Trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KN035 in combination with trastuzumab and docetaxel
- interventionNames
- Biological: KN035
- Biological: Trastuzumab
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Objective response
- timeFrame
- 12 months
- description
- To estimate the overall response rate (CR + PR) of KN035 in combination with trastuzumab and docetaxel in patients with recurrent or metastatic HER2-positive breast cancer. • Overall Response rate will include confirmed complete response (CR) + confirmed partial response (PR), as determined as per RECIST v1.1 criteria and assessed by the local investigator
Secondary outcomes (1)
- measure
- Adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Female subjects with age 18 to 70 (inclusive) years at the time of consent * LVEF ≥50% at baseline * ECOG performance status of 0-1 * Have not received 1L treatment for recurrent or metastatic breast cancer * Adequate organ function Exclusion Criteria: * History of exposure to the cumulative doses of doxorubicin \> 400 mg / m2 or equivalent * History of autoimmune diseases * Active brain metastasis * Concurrent diseases that compromise patient's safety
References
Publications (0)
Data not yet available