A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: SHR-A1811：Pyrotinib; Drug: SHR-A1811；Pertuzumab; Drug: SHR-A1811；Adebrelimab; Drug: SHR-A1811；Albumin paclitaxel

• Registration Number: NCT05353361
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-29
• Study Start: 2022-05-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 402

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-A1811combined Pyrotinib	SHR-A1811：Pyrotinib	-
SHR-A1811Combined Pertuzumab	SHR-A1811；Pertuzumab	-
SHR-A1811Combined Adebrelimab	SHR-A1811；Adebrelimab	-
SHR-A1811Combined Albumin-bound Paclitaxel	SHR-A1811；Albumin paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Objective response rate（Phase II (efficacy expansion phase)）	Two years after the last subject was enrolled in the group
Incidence and severity of serious adverse events (SAE)（Phase I (dose exploration phase) ）	from Day1 to 40 or 90 days after last dose
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

Secondary Outcome Measures

Name	Time	Method
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
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: 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
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
Immunogenicity of Adebrelimab（Phase II secondary study endpoint）	through study completion, an average of 2 years

Trial Locations

Locations (1)

Jiangsu Provincial People's Hospital; 🇨🇳 Nanjing, Jiangsu, China