Trial Title:
A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
NCT ID:
NCT06434597
Condition:
Biliary Tract or Colorectal Cancer With Her2-positive/Mutated
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SPH5030
Description:
SPH5030：Oral, QD, 600mg
Arm group label:
SPH5030
Summary:
To evaluate the efficacy and safety of SPH5030 tablets in subjects with
Her2-positive/mutated biliary tract OR colorectal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally
advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma
2. HER2 positive or HER2 gene mutation;
3. Meet the requirements of previous treatment;
4. ECOG performance status of 0 or 1；
5. Expected survival ≥ 3 months;
6. No serious abnormalities in hematopoietic function, liver or kidney function;
7. Females who are not pregnant, non-lactating.. Subjects who complied with the
contraceptive requirements of the protocol.;
8. Fully informed subjects who voluntarily sign the ICF.
Exclusion Criteria:
1. Subjects who have previously received anti-HER2 molecular targeted therapy;
2. Subjects who have been treated with any other clinical trial drug within 4 weeks
prior to the first dose;
3. Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases;
Subjects with severe lung disease; 4. Subjects who may have conditions that affect
the absorption, distribution, metabolism, or excretion of the study drug determined
by the investigator;
5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with
other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with
clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B
and C at screening, have a history of immunodeficiency, or other acquired、congenital
immunodeficiency diseases, or have a history of organ transplantation; 9. Other
situations that do not meet the requirements of the protolol.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Friendship Hospital，Capital Medical University
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Bangwei Cao
Facility:
Name:
Chinese PLA General hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianming Xu
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitao Zhao
Facility:
Name:
The Second Affiliatedf Hospital of AFMU
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Haichuan Su
Facility:
Name:
XiangYa Hospital CentralSouth University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuejun Gong
Contact backup:
Last name:
Jie Ge
Facility:
Name:
Changzhi People's Hospital
Address:
City:
Changzhi
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhao
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianwei Yang
Facility:
Name:
General Hospital of Fuzhou
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Dongliang Li
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Dong Ma
Facility:
Name:
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongming Pan
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Haijun Zhong
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanqiao Zhang
Facility:
Name:
Anhui Provincial Cancer Hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Yifu He
Facility:
Name:
Hengshui People's Hospital
Address:
City:
Hengshui
Country:
China
Status:
Recruiting
Contact:
Last name:
Daqing Wang
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Contact:
Last name:
Yunfeng Li
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiyu Chen
Facility:
Name:
Shanghai General Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Qi Li
Facility:
Name:
The Third Affiliated Hospital of Air Force Medical University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Qian Zhang
Facility:
Name:
Zhongshan Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Houbao Liu
Contact backup:
Last name:
Huichuan Sun
Facility:
Name:
Shantou University Medical College Cancer Hospital
Address:
City:
Shantou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Jiang
Facility:
Name:
Liaoning Cancer Hospital
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingdong Zhang
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenhui Yang
Facility:
Name:
Tianjin Medical University Cancer institute & Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhanyu Pan
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Nie
Facility:
Name:
Affiliated Hospital of Jiangnan University
Address:
City:
Wuxi
Country:
China
Status:
Recruiting
Contact:
Last name:
Gaoxiang
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Contact:
Last name:
Enxiao Li
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Ye
Facility:
Name:
Xiangyang Central Hospital
Address:
City:
Xiangyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Gong
Facility:
Name:
Yantai Yuhuangding Hospital
Address:
City:
Yantai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Chen
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaobing Chen
Start date:
July 17, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Shanghai Pharmaceuticals Holding Co., Ltd
Agency class:
Industry
Source:
Shanghai Pharmaceuticals Holding Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06434597
