NCT05353361RecruitingPhase 2
A Phase Ib/II Multicenter, Open-Label Clinical Trial of SHR-A1811 Injection in Combination With Pyrotinib or Pertuzumab or Adebrelimab or Paclitaxel for Injection (Albumin Bound) in Breast Cancer
Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country402 target enrollmentStarted: May 23, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 402
- Locations
- 1
- Primary Endpoint
- Objective response rate（Phase II (efficacy expansion phase)）
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged 18 to 75 (inclusive)
- •Breast cancer confirmed by histology or cytology.
- •ECOG score is 0 or 1
- •An expected survival of ≥ 12 weeks
- •At least one measurable lesion according to RECIST v1.1 criteria
- •Have adequate renal and hepatic function
- •Patients voluntarily joined the study and signed informed consent
Exclusion Criteria
- •Have other malignancies within the past 5 years
- •Active central nervous system metastasis without surgery or radiotherapy
- •Presence with uncontrollable third space effusion
- •Have undergone other anti-tumor treatment within 4 weeks before the first dose
- •Immunosuppressant or systemic hormone therapy was used within 2 weeks prior to the first dose
- •Any active autoimmune disease or a history of autoimmune disease
- •A history of immune deficiency
- •Clinically significant cardiovascular disorders
- •Clinically significant history of lung disease
- •The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
- •Known hereditary or acquired bleeding tendency
- •Active hepatitis and liver cirrhosis
- •Presence of other serious physical or mental diseases or laboratory abnormalities
Arms & Interventions
SHR-A1811Combined Albumin-bound Paclitaxel
Experimental
Intervention: SHR-A1811；Albumin paclitaxel (Drug)
SHR-A1811combined Pyrotinib
Experimental
Intervention: SHR-A1811：Pyrotinib (Drug)
SHR-A1811Combined Pertuzumab
Experimental
Intervention: SHR-A1811；Pertuzumab (Drug)
SHR-A1811Combined Adebrelimab
Experimental
Intervention: SHR-A1811；Adebrelimab (Drug)
Outcomes
Primary Outcomes
Objective response rate（Phase II (efficacy expansion phase)）
Time Frame: Two years after the last subject was enrolled in the group
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
DLT（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
Secondary Outcomes
- Immunogenicity of Adebrelimab（Phase II secondary study 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)
- Immunogenicity of SHR-A1811（Phase I secondary endpoint）(through study completion, an average of 2 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 SHR-A1811（Phase II secondary study 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)
- PK parameter: Cmin 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)
- Duration of response（Phase I secondary endpoint）(from first dose to disease progression or death, whichever comes first, up to 3 years)
- PK parameter: C4h of Pyrotinib（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)
- 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)
- 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)
- PK parameter: Cmin 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)
- 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)
- 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)
Investigators
Study Sites (1)
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