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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.
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.
Details
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 300 |
| Start date | 2023-04 |
| Completion | 2025-02-27 |
Conditions
- HER2 Low Advanced or Metastatic Breast Cancer
Interventions
- SHR-A1811 & Dalpiciclib Isethionate Tablets
- SHR-A1811 & Fulvestrant
- SHR-A1811 & Bevacizumab injection
Primary outcomes
- DLT(Phase I (dose-finding phase) main study endpoint) — At the end of cycle 1(each cycle is 28 days for SHR-A1811+ fulvestrant; each cycle is 21 days for SHR-A1811+other therapies.
- AE(Phase I (dose-finding phase) main study endpoint) — Up to follow-up period, approximately 24 months
- Incidence and severity of serious adverse events (SAE)(Phase I (dose-finding phase) main study endpoint) — Up to follow-up period, approximately 24 months
- Objective response rate(The main end points of the second stage (efficacy expansion stage)) — Until progression, assessed up to approximately 24 months