Trials / Unknown
UnknownNCT05845138
A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
An Open-Label, Multi-center Phase Ⅰb/Ⅱ Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study is being conducted to evaluate the safety, tolerability， preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low HER2 expression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-A1811 for injection ; capecitabine | SHR-A1811 for injection; Capecitabine tablets |
Timeline
- Start date
- 2023-07-25
- Primary completion
- 2024-12-31
- Completion
- 2025-12-31
- First posted
- 2023-05-06
- Last updated
- 2023-08-01
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05845138. Inclusion in this directory is not an endorsement.