Back to resultsA Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-A1811：Pyrotinib
SHR-A1811；Pertuzumab
SHR-A1811；Adebrelimab
SHR-A1811；Albumin paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Women aged 18 to 75 (inclusive)
- HER2 positive (IHC3+ or ISH+) confirmed by histology or cytology is not resectable or metastatic breast cancer.
- ECoG score is 0 or 1
- Expected survival ≥ 12 weeks
- According to RECIST v1 1 standard at least one measurable lesion。
- Good level of organ function
- Patients voluntarily joined the study and signed informed consent
Exclusion Criteria:
- Other malignant tumors in the past 5 years
- Active central nervous system metastasis without surgery or radiotherapy
- There is uncontrollable third space effusion
- Receive other anti-tumor treatment within 4 weeks before the first
- medicationImmunosuppressant or systemic hormone therapy was used within 2 weeks before the first medication
- Any active autoimmune disease or history of autoimmune disease
- History of immune deficiency
- Clinically significant cardiovascular diseases
- Clinically significant history of lung disease
- The toxicity caused by previous anti-tumor treatment has not recovered to ≤ grade I
- There is a tendency of hereditary or acquired bleeding and thrombosis
- Active hepatitis and liver cirrhosis
- There are other serious physical or mental diseases or laboratory abnormalities
Sites / Locations
- Jiangsu Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
SHR-A1811combined Pyrotinib
SHR-A1811Combined Pertuzumab
SHR-A1811Combined Adebrelimab
SHR-A1811Combined Albumin-bound Paclitaxel
Arm Description
Outcomes
Primary Outcome Measures
DLT（Phase I (dose exploration phase) ）
AE（Phase I (dose exploration phase) ）
Incidence and severity of serious adverse events (SAE)（Phase I (dose exploration phase) ）
Objective response rate（Phase II (efficacy expansion phase)）
Secondary Outcome Measures
PK parameter: Cmin of SHR-A1811（Phase I secondary endpoint）
PK parameter: Cmax of SHR-A1811（Phase I secondary endpoint）
PK parameter: AUC0-t of SHR-A1811（Phase I secondary endpoint）
PK parameter: Cmin of Pyrotinib（Phase I secondary endpoint）
PK parameter: C4h of Pyrotinib（Phase I secondary endpoint）
PK parameter: Cmin of Adebrelimab（Phase I secondary endpoint）
Immunogenicity of SHR-A1811（Phase I secondary endpoint）
Immunogenicity of Adebrelimab（Phase I secondary endpoint）
Objective Response Rate（Phase I secondary endpoint）
Duration of response（Phase I secondary endpoint）
Progression Free Survival（Phase I secondary endpoint）
AE（Phase II secondary study endpoint）
Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint）
PK parameter: Cmin, Cmax, and AUC0-t of SHR-A1811（Phase II secondary study endpoint）
PK parameter: Cmin, C4h of Pyrotinib:（Phase II secondary study endpoint）
PK parameter: Cmin of Adebrelimab（Phase II secondary study endpoint）
Immunogenicity of SHR-A1811（Phase II secondary study endpoint）
Immunogenicity of Adebrelimab（Phase II secondary study endpoint）
Duration of response（Phase II secondary study endpoint）
Progression Free Survival（Phase II secondary study endpoint）
Event-Free Survival Rate（Phase II secondary study endpoint）
Full Information
NCT ID
NCT05353361
First Posted
April 19, 2022
Last Updated
September 14, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05353361
Brief Title
A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
402 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-A1811combined Pyrotinib
Arm Type
Experimental
Arm Title
SHR-A1811Combined Pertuzumab
Arm Type
Experimental
Arm Title
SHR-A1811Combined Adebrelimab
Arm Type
Experimental
Arm Title
SHR-A1811Combined Albumin-bound Paclitaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-A1811：Pyrotinib
Intervention Description
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib：Tablet, 160mg / tablet, 80mg / tablet, oral
Intervention Type
Drug
Intervention Name(s)
SHR-A1811；Pertuzumab
Intervention Description
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab：Injection, 420 Mg (14 ml) / bottle, intravenous drip
Intervention Type
Drug
Intervention Name(s)
SHR-A1811；Adebrelimab
Intervention Description
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab：Injection, 12ml: 0.6g/bottle, intravenous drip
Intervention Type
Drug
Intervention Name(s)
SHR-A1811；Albumin paclitaxel
Intervention Description
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel：Injection, 100mg / box, intravenous drip
Primary Outcome Measure Information:
Title
DLT（Phase I (dose exploration phase) ）
Time Frame
21 days after the first administration of each subject
Title
AE（Phase I (dose exploration phase) ）
Time Frame
from Day1 to 40 or 90 days after last dose
Title
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
Title
Objective response rate（Phase II (efficacy expansion phase)）
Time Frame
Two years after the last subject was enrolled in the group
Secondary Outcome Measure Information:
Title
PK parameter: Cmin of SHR-A1811（Phase I secondary endpoint）
Time Frame
through study completion, an average of 2 years
Title
PK parameter: Cmax of SHR-A1811（Phase I secondary endpoint）
Time Frame
through study completion, an average of 2 years
Title
PK parameter: AUC0-t of SHR-A1811（Phase I secondary endpoint）
Time Frame
through study completion, an average of 2 years
Title
PK parameter: Cmin of Pyrotinib（Phase I secondary endpoint）
Time Frame
through study completion, an average of 2 years
Title
PK parameter: C4h of Pyrotinib（Phase I secondary endpoint）
Time Frame
through study completion, an average of 2 years
Title
PK parameter: Cmin of Adebrelimab（Phase I secondary endpoint）
Time Frame
through study completion, an average of 2 years
Title
Immunogenicity of SHR-A1811（Phase I secondary endpoint）
Time Frame
through study completion, an average of 2 years
Title
Immunogenicity of Adebrelimab（Phase I secondary endpoint）
Time Frame
through study completion, an average of 2 years
Title
Objective Response Rate（Phase I secondary endpoint）
Time Frame
from first dose to disease progression or death, whichever comes first, up to 3 years
Title
Duration of response（Phase I secondary endpoint）
Time Frame
from first dose to disease progression or death, whichever comes first, up to 3 years
Title
Progression Free Survival（Phase I secondary endpoint）
Time Frame
from first dose to disease progression or death, whichever comes first, up to 3 years
Title
AE（Phase II secondary study endpoint）
Time Frame
from Day1 to 40 or 90 days after last dose
Title
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
Title
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
Title
PK parameter: Cmin, C4h of Pyrotinib:（Phase II secondary study endpoint）
Time Frame
through study completion, an average of 2 years
Title
PK parameter: Cmin of Adebrelimab（Phase II secondary study endpoint）
Time Frame
through study completion, an average of 2 years
Title
Immunogenicity of SHR-A1811（Phase II secondary study endpoint）
Time Frame
through study completion, an average of 2 years
Title
Immunogenicity of Adebrelimab（Phase II secondary study endpoint）
Time Frame
through study completion, an average of 2 years
Title
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
Title
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
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoxue Pi
Phone
0518-82342973
Email
Xiaoxue.pi@hengrui.com
Facility Information:
Facility Name
Jiangsu Provincial People's Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongmei Yin
First Name & Middle Initial & Last Name & Degree
Jinhai Tang
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer
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