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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353361
• Other study ID #: SHR-A1811-II-202
• Status: Recruiting
• Phase: Phase 2
• Start date: May 23, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Xiaoxue Pi
• Phone: 0518-82342973
• Email: Xiaoxue.pi[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 402
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• SHR-A1811:Pyrotinib
SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib:Tablet, 160mg / tablet, 80mg / tablet, oral
• SHR-A1811;Pertuzumab
SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab:Injection, 420 Mg (14 ml) / bottle, intravenous drip
• SHR-A1811;Adebrelimab
SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab:Injection, 12ml: 0.6g/bottle, intravenous drip
• SHR-A1811;Albumin paclitaxel
SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel:Injection, 100mg / box, intravenous drip

Locations

Country	Name	City	State
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT(Phase I (dose exploration phase) )		21 days after the first administration of each subject
Primary	AE(Phase I (dose exploration phase) )		from Day1 to 40 or 90 days after last dose
Primary	Incidence and severity of serious adverse events (SAE)(Phase I (dose exploration phase) )		from Day1 to 40 or 90 days after last dose
Primary	Objective response rate(Phase II (efficacy expansion phase))		Two years after the last subject was enrolled in the group
Secondary	PK parameter: Cmin of SHR-A1811(Phase I secondary endpoint)		through study completion, an average of 2 years
Secondary	PK parameter: Cmax of SHR-A1811(Phase I secondary endpoint)		through study completion, an average of 2 years
Secondary	PK parameter: AUC0-t of SHR-A1811(Phase I secondary endpoint)		through study completion, an average of 2 years
Secondary	PK parameter: Cmin of Pyrotinib(Phase I secondary endpoint)		through study completion, an average of 2 years
Secondary	PK parameter: C4h of Pyrotinib(Phase I secondary endpoint)		through study completion, an average of 2 years
Secondary	PK parameter: Cmin of Adebrelimab(Phase I secondary endpoint)		through study completion, an average of 2 years
Secondary	Immunogenicity of SHR-A1811(Phase I secondary endpoint)		through study completion, an average of 2 years
Secondary	Immunogenicity of Adebrelimab(Phase I secondary endpoint)		through study completion, an average of 2 years
Secondary	Objective Response Rate(Phase I secondary endpoint)		from first dose to disease progression or death, whichever comes first, up to 3 years
Secondary	Duration of response(Phase I secondary endpoint)		from first dose to disease progression or death, whichever comes first, up to 3 years
Secondary	Progression Free Survival(Phase I secondary endpoint)		from first dose to disease progression or death, whichever comes first, up to 3 years
Secondary	AE(Phase II secondary study endpoint)		from Day1 to 40 or 90 days after last dose
Secondary	Incidence and severity of serious adverse events (SAE)(Phase II secondary study endpoint)		from Day1 to 40 or 90 days after last dose
Secondary	PK parameter: Cmin, Cmax, and AUC0-t of SHR-A1811(Phase II secondary study endpoint)		through study completion, an average of 2 years
Secondary	PK parameter: Cmin, C4h of Pyrotinib:(Phase II secondary study endpoint)		through study completion, an average of 2 years
Secondary	PK parameter: Cmin of Adebrelimab(Phase II secondary study endpoint)		through study completion, an average of 2 years
Secondary	Immunogenicity of SHR-A1811(Phase II secondary study endpoint)		through study completion, an average of 2 years
Secondary	Immunogenicity of Adebrelimab(Phase II secondary study endpoint)		through study completion, an average of 2 years
Secondary	Duration of response(Phase II secondary study endpoint)		from first dose to disease progression or death, whichever comes first, up to 3 years
Secondary	Progression Free Survival(Phase II secondary study endpoint)		from first dose to disease progression, or death, whichever comes first, up to 3 years
Secondary	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