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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
402
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib：Tablet, 160mg / tablet, 80mg / tablet, oral
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab：Injection, 420 Mg (14 ml) / bottle, intravenous drip
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab：Injection, 12ml: 0.6g/bottle, intravenous drip
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
RECRUITINGDLT（Phase I (dose exploration phase) ）
Time frame: 21 days after the first administration of each subject
AE（Phase I (dose exploration phase) ）
Time frame: from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)（Phase I (dose exploration phase) ）
Time frame: from Day1 to 40 or 90 days after last dose
Objective response rate（Phase II (efficacy expansion phase)）
Time frame: Two years after the last subject was enrolled in the group
PK parameter: Cmin of SHR-A1811（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: Cmax of SHR-A1811（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: AUC0-t of SHR-A1811（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: Cmin of Pyrotinib（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: C4h of Pyrotinib（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: Cmin of Adebrelimab（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
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SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel：Injection, 100mg / box, intravenous drip
Immunogenicity of SHR-A1811（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
Immunogenicity of Adebrelimab（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
Objective Response Rate（Phase I secondary endpoint）
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
Duration of response（Phase I secondary endpoint）
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
Progression Free Survival（Phase I secondary endpoint）
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
AE（Phase II secondary study endpoint）
Time frame: from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint）
Time frame: 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）
Time frame: through study completion, an average of 2 years
PK parameter: Cmin, C4h of Pyrotinib:（Phase II secondary study endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: Cmin of Adebrelimab（Phase II secondary study endpoint）
Time frame: through study completion, an average of 2 years
Immunogenicity of SHR-A1811（Phase II secondary study endpoint）
Time frame: through study completion, an average of 2 years
Immunogenicity of Adebrelimab（Phase II secondary study endpoint）
Time frame: through study completion, an average of 2 years
Duration of response（Phase II secondary study endpoint）
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
Progression Free Survival（Phase II secondary study endpoint）
Time frame: from first dose to disease progression, or death, whichever comes first, up to 3 years
Event-Free Survival Rate（Phase II secondary study endpoint）
Time frame: from first dose to disease progression, disease recurrence, or death, whichever comes first, up to 3 years