Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGSHR-A1811：Pyrotinib
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib：Tablet, 160mg / tablet, 80mg / tablet, oral
DRUGSHR-A1811；Pertuzumab
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab：Injection, 420 Mg (14 ml) / bottle, intravenous drip
DRUGSHR-A1811；Adebrelimab
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab：Injection, 12ml: 0.6g/bottle, intravenous drip
DRUGSHR-A1811；Albumin paclitaxel
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel：Injection, 100mg / box, intravenous drip
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 18 to 75 (inclusive) 2. Breast cancer confirmed by histology or cytology. 3. ECOG score is 0 or 1 4. An expected survival of ≥ 12 weeks 5. At least one measurable lesion according to RECIST v1.1 criteria 6. Have adequate renal and hepatic function 7. Patients voluntarily joined the study and signed informed consent
Exclusion criteria
1. Have other malignancies within the past 5 years 2. Active central nervous system metastasis without surgery or radiotherapy 3. Presence with uncontrollable third space effusion 4. Have undergone other anti-tumor treatment within 4 weeks before the first dose 5. Immunosuppressant or systemic hormone therapy was used within 2 weeks prior to the first dose 6. Any active autoimmune disease or a history of autoimmune disease 7. A history of immune deficiency 8. Clinically significant cardiovascular disorders 9. Clinically significant history of lung disease 10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I 11. Known hereditary or acquired bleeding tendency 12. Active hepatitis and liver cirrhosis 13. Presence of other serious physical or mental diseases or laboratory abnormalities
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Immunogenicity of Adebrelimab（Phase II secondary study endpoint） | through study completion, an average of 2 years |
| 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 |
| 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 |
| AE（Phase II secondary study endpoint） | from Day1 to 40 or 90 days after last dose |
| 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 |
| PK parameter: AUC0-t of SHR-A1811（Phase I secondary endpoint） | through study completion, an average of 2 years |
Countries
China
Contacts
Primary ContactXiaoxue Pi
Outcome results
None listed