A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.

Breast Cancer Clinical Trial

Official title:

An Open-Label, Multi-center Phase Ⅰb/Ⅱ Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05845138
• Other study ID #: SHR-A1811-207
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 25, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Shuchao Wu
• Phone: +0518-81220121
• Email: shuchao.wu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to evaluate the safety, tolerability， preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low HER2 expression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Women aged 18 to 75 (inclusive).

2. HER2 low expression unresectable or metastatic 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. Women of childbearing potential (WOCBP) subjects must agree to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding.

7. Patients voluntarily joined the study and signed informed consent, had good compliance and willingness to cooperate with the visit and study related procedures.

Exclusion Criteria:

1. Have other malignancies within the past 5 years.

2. Presence with uncontrollable third space effusion.

3. Have surgical treatment, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drug clinical studies within 4 weeks before the first medication.

4. Accepted antibody drug conjugates containing etoisomercan derivative topoisomerase I inhibitor.

5. Clinically significant cardiovascular disorders.

6. Presence of active hepatitis B, hepatitis C, cirrhosis,or serious infected persons requiring antibiotic, antiviral or antifungal control.

7. The toxicity from previous anti-tumor treatment has not recovered to = grade I.

8. Known to be allergic to any study drug or any of its excipients, or to humanized monoclonal antibody products.

9. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption.

10. Presence of other serious physical or mental diseases or laboratory abnormalities.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• SHR-A1811 for injection ; capecitabine
SHR-A1811 for injection; Capecitabine tablets

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijng
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Shandong Cancer Hospital&Institute	Jinan	Shandong
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College	Nanning	Guangxi
China	Shantou Central Hospital	Shantou	Guangzhou
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Wenzhou People's Hospital	Wenzhou	Zhejiang
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT(Phase I (dose exploration phase) ) [ Time Frame: 21 days after the first administration of each subject ]		21 days after the first administration of each subject ]
Primary	Incidence of AEs(Phase I (dose exploration phase) )		from Day1 to 40 days after last dose
Primary	Incidence of SAEs(Phase I (dose exploration phase) )		from Day1 to 40 days after last dose
Primary	Objective response rate(Phase II (efficacy expansion phase))		One year after the last subject was enrolled in the group
Secondary	Duration of response(DoR )		One year after the last subject was enrolled in the group
Secondary	Progression Free Survival(PFS)		One year after the last subject was enrolled in the group
Secondary	Objective response rate(Phase I (dose exploration phase))		One year after the last subject was enrolled in the group
Secondary	Incidence of AEs(Phase II (efficacy expansion phase))		from Day1 to 40 days after last dose
Secondary	Incidence of SAEs(Phase II (efficacy expansion phase))		from Day1 to 40 days after last dose