Trials / Unknown
UnknownNCT05792410
A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
An Open, Multicenter Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Dalpiciclib, Fulvestrant, Bevacizumab or Letrozole/Anastrozole in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-A1811 & Dalpiciclib Isethionate Tablets | SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Dalpiciclib Isethionate Tablets：Tablet, 25mg / tablet, 50mg / tablet, 125mg / tablet, 150mg / tablet, oral |
| DRUG | SHR-A1811 & Fulvestrant | SHR-A1811：Lyophilized powder injection, 100mg / bottle, intramuscular Fulvestrant：Injection, 5 ml: 0.25g/bottle, intramuscular |
| DRUG | SHR-A1811 & Bevacizumab injection | SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Bevacizumab injection: injection, 100mg / bottle, intravenous drip |
Timeline
- Start date
- 2023-04-01
- Primary completion
- 2024-02-27
- Completion
- 2025-02-27
- First posted
- 2023-03-31
- Last updated
- 2023-03-31
Source: ClinicalTrials.gov record NCT05792410. Inclusion in this directory is not an endorsement.