A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446260
• Other study ID #: SHR-A1811-I-101
• Status: Recruiting
• Phase: Phase 1
• Start date: September 3, 2020
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Sherry Zhu, MD, PhD
• Phone: +86 021-61053363
• Email: xiaoyu.zhu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• LVEF = 50% by either ECHO or MUGA
• Has adequate renal and hepatic function
• Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment

Exclusion Criteria:

• History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
• Known hereditary or acquired bleeding and thrombotic tendency

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• SHR-A1811
be administered via intravenous (IV) infusion

Locations

Country	Name	City	State
Australia	Southern Oncology Clinical Research Unit	Bedford Park	South Australia
Australia	Peninsula and South Eastern Haematology & Oncology Group	Frankston	Victoria
Australia	Macquarie University Hospital	Macquarie	New South Wales
Australia	Alfred Hospital	Melbourne
Australia	Nucleus Network	Melbourne	Victoria
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	The first affiliated hospital of bengbu medical college	Bengbu	Anhui
China	The First Hospital of Jilin University	Changchuan	Jilin
China	Hunan cancer hospital	Changsha	Hunan
China	Xiangya hospital central south university	Changsha	Hunan
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	Nanfang Hospital	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The second affiliated hospital Zhejiang university school of medicine	Hangzhou	Zhejiang
China	Zhejiang provincial people's hospital	Hangzhou	Zhejiang
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Fudan University Shanghai cancer center	Shanghai	Shanghai
China	Fudan Unversity Zhongshan Hospital	Shanghai	Shanghai
China	Shengjing Hospital of China medical university	Shengyang	Liaoning
China	Tianjin medical university cancer institute&hoospital	Tianjin	Tianjin
China	Hubei cancer hospital	Wuhan	Hubei
China	Zhongnan hospital of Wuhan university	Wuhan	Hubei
China	Henan cancer Hospital	Zhengzhou	Henan
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan
United States	Montefiore-Einstein Center for Cancer Care	Bronx	New York
United States	Gabrail Cancer Center	Canton	Ohio
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	Greenville Hospital System	Greenville	South Carolina
United States	Prisma-Health Cancer Institute	Greenville	South Carolina
United States	Center for Oncology and Blood Disorders	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.	Atridia Pty Ltd.

Countries where clinical trial is conducted

United States,  Australia,  China,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (AEs)	Frequency and seriousness of treatment emergent adverse events (TEAEs)	From Day1 to 90 days after last dose
Secondary	PK parameter: Tmax of SHR-A1811	Time to maximal concentration (Tmax) of SHR-A1811	Through study completion, an average of 1 year
Secondary	PK parameter: Cmax of SHR-A1811	Maximal concentration (Cmax) of SHR-A1811	Through study completion, an average of 1 year
Secondary	PK parameter: AUC0-t of SHR-A1811	AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811	Through study completion, an average of 1 year
Secondary	Immunogenicity of SHR-A1811	Including anti-drug antibody and/or neutralizing antibody	Through study completion, an average of 1 year
Secondary	Tumor response using RECIST 1.1	RECIST=Response Evaluation Criteria in Solid Tumors Assessment of tumor response until disease progression or death to evaluate the efficacy of SHR-A1811 up to 30 months	From first dose to disease progression or death, whichever comes first, up to 30 months