Trials / Unknown
UnknownNCT04034823
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | KN035 | KN035 5 mg/kg s.c. Q3W |
| BIOLOGICAL | Trastuzumab | 8 mg/kg IV loading followed by 6 mg/kg Q3W IV |
| DRUG | Docetaxel | 100 mg/m2 Q3W IV |
Timeline
- Start date
- 2019-09-01
- Primary completion
- 2021-01-01
- Completion
- 2022-01-01
- First posted
- 2019-07-26
- Last updated
- 2019-07-26
Source: ClinicalTrials.gov record NCT04034823. Inclusion in this directory is not an endorsement.