Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety, tolerability and efficacy of SHR-A1811 in combination with pyrotinib or pertuzumab or adebrelimab or albumin-bound paclitaxel in patients with breast cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1811combined Pyrotinib | Experimental |
| |
| SHR-A1811Combined Pertuzumab | Experimental |
| |
| SHR-A1811Combined Adebrelimab | Experimental |
| |
| SHR-A1811Combined Albumin-bound Paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811:Pyrotinib | Drug | SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib:Tablet, 160mg / tablet, 80mg / tablet, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT(Phase I (dose exploration phase) ) | 21 days after the first administration of each subject | |
| AE(Phase I (dose exploration phase) ) | from Day1 to 40 or 90 days after last dose | |
| Incidence and severity of serious adverse events (SAE)(Phase I (dose exploration phase) ) | from Day1 to 40 or 90 days after last dose | |
| Objective response rate(Phase II (efficacy expansion phase)) | Two years after the last subject was enrolled in the group |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Cmin of SHR-A1811(Phase I secondary endpoint) | through study completion, an average of 2 years | |
| PK parameter: Cmax of SHR-A1811(Phase I secondary endpoint) | through study completion, an average of 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoxue Pi | Contact | 0518-82342973 | Xiaoxue.pi@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial People's Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
This study is a multicenter, open-label, dose exploration and efficacy expansion phase Ib / II study. The first stage is the dose exploration phase, which uses the 3 + 3 escalation design; The second stage is the curative effect expansion phase.
Not provided
Not provided
Not provided
Not provided
| SHR-A1811;Pertuzumab | Drug | SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab:Injection, 420 Mg (14 ml) / bottle, intravenous drip |
|
| SHR-A1811;Adebrelimab | Drug | SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab:Injection, 12ml: 0.6g/bottle, intravenous drip |
|
| SHR-A1811;Albumin paclitaxel | Drug | SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel:Injection, 100mg / box, intravenous drip |
|
| PK parameter: AUC0-t of SHR-A1811(Phase I secondary endpoint) | through study completion, an average of 2 years |
| PK parameter: Cmin of Pyrotinib(Phase I secondary endpoint) | through study completion, an average of 2 years |
| PK parameter: C4h of Pyrotinib(Phase I secondary endpoint) | through study completion, an average of 2 years |
| PK parameter: Cmin of Adebrelimab(Phase I secondary endpoint) | through study completion, an average of 2 years |
| Immunogenicity of SHR-A1811(Phase I secondary endpoint) | through study completion, an average of 2 years |
| Immunogenicity of Adebrelimab(Phase I secondary endpoint) | through study completion, an average of 2 years |
| Objective Response Rate(Phase I secondary endpoint) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| Duration of response(Phase I secondary endpoint) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| Progression Free Survival(Phase I secondary endpoint) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| AE(Phase II secondary study endpoint) | from Day1 to 40 or 90 days after last dose |
| Incidence and severity of serious adverse events (SAE)(Phase II secondary study endpoint) | from Day1 to 40 or 90 days after last dose |
| PK parameter: Cmin, Cmax, and AUC0-t of SHR-A1811(Phase II secondary study endpoint) | through study completion, an average of 2 years |
| PK parameter: Cmin, C4h of Pyrotinib:(Phase II secondary study endpoint) | through study completion, an average of 2 years |
| PK parameter: Cmin of Adebrelimab(Phase II secondary study endpoint) | through study completion, an average of 2 years |
| Immunogenicity of SHR-A1811(Phase II secondary study endpoint) | through study completion, an average of 2 years |
| Immunogenicity of Adebrelimab(Phase II secondary study endpoint) | through study completion, an average of 2 years |
| Duration of response(Phase II secondary study endpoint) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| Progression Free Survival(Phase II secondary study endpoint) | from first dose to disease progression, or death, whichever comes first, up to 3 years |
| Event-Free Survival Rate(Phase II secondary study endpoint) | from first dose to disease progression, disease recurrence, or death, whichever comes first, up to 3 years |
| D017437 |
| Skin and Connective Tissue Diseases |