Clinical trial NCT04446260: A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Atridia Pty Ltd.
First posted: 2020-06-24
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: From Day1 to 90 days after last dose
Secondary outcomes:
measure: PK parameter: Tmax of SHR-A1811
timeFrame: Through study completion, an average of 1 year
measure: PK parameter: Cmax of SHR-A1811
timeFrame: Through study completion, an average of 1 year
measure: PK parameter: AUC0-t of SHR-A1811
timeFrame: Through study completion, an average of 1 year
measure: Immunogenicity of SHR-A1811
timeFrame: Through study completion, an average of 1 year
measure: Tumor response using RECIST 1.1
timeFrame: From first dose to disease progression or death, whichever comes first, up to 30 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore-Einstein Center for Cancer Care
state: New York
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Macquarie
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Bedford Park
country: Australia
facility: Southern Oncology Clinical Research Unit
state: South Australia
city: Frankston
country: Australia
facility: Peninsula and South Eastern Haematology & Oncology Group
state: Victoria
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
city: Bengbu
country: China
facility: The first affiliated hospital of bengbu medical college
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Fujian
country: China
facility: Fujian Cancer Hospital
state: Fuzhou
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Zhongnan hospital of Wuhan university
state: Hubei
city: Wuhan
country: China
facility: Hubei cancer hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya hospital central south university
state: Hunan
city: Changsha
country: China
facility: Hunan cancer hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Shengyang
country: China
facility: Shengjing Hospital of China medical university
state: Liaoning
city: Shanghai
country: China
facility: Fudan University Shanghai cancer center
state: Shanghai
city: Shanghai
country: China
facility: Fudan Unversity Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine Renji Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin medical university cancer institute&hoospital
state: Tianjin
city: Hangzhou
country: China
facility: The second affiliated hospital Zhejiang university school of medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang provincial people's hospital
state: Zhejiang
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
References: