Actively Recruiting
A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2025-08-17
60
Participants Needed
30
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
CONDITIONS
Official Title
A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma
- HER2 positive or HER2 gene mutation
- Meet the requirements of previous treatment
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- No serious abnormalities in hematopoietic function, liver or kidney function
- Females who are not pregnant, non-lactating, and comply with contraceptive requirements
- Fully informed subjects who voluntarily sign the informed consent form
You will not qualify if you...
- Previously received anti-HER2 molecular targeted therapy
- Treated with any other clinical trial drug within 4 weeks prior to the first dose
- Uncontrolled or severe cardiovascular and cerebrovascular diseases
- Severe lung disease
- Conditions affecting absorption, distribution, metabolism, or excretion of the study drug
- Taking potent CYP3A4 or CYP2C8 inhibitors or inducers
- Other malignancies within the past 5 years
- CNS metastasis with clinical symptoms
- Positive for hepatitis B or C at screening, history of immunodeficiency, or organ transplantation
- Other situations not meeting protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Beijing Friendship Hospital，Capital Medical University
Beijing, China
Actively Recruiting
2
Chinese PLA General hospital
Beijing, China
Actively Recruiting
3
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
4
The Second Affiliatedf Hospital of AFMU
Beijing, China
Actively Recruiting
5
XiangYa Hospital CentralSouth University
Changsha, China
Actively Recruiting
6
Changzhi People's Hospital
Changzhi, China
Actively Recruiting
7
Fujian Cancer Hospital
Fuzhou, China
Actively Recruiting
8
General Hospital of Fuzhou
Fuzhou, China
Actively Recruiting
9
Guangdong Provincial People's Hospital
Guangzhou, China
Actively Recruiting
10
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
11
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
12
Harbin Medical University Cancer Hospital
Harbin, China
Actively Recruiting
13
Anhui Provincial Cancer Hospital
Hefei, China
Actively Recruiting
14
Hengshui People's Hospital
Hengshui, China
Actively Recruiting
15
Yunnan Cancer Hospital
Kunming, China
Actively Recruiting
16
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
17
Shanghai General Hospital
Shanghai, China
Actively Recruiting
18
The Third Affiliated Hospital of Air Force Medical University
Shanghai, China
Actively Recruiting
19
Zhongshan Hospital
Shanghai, China
Actively Recruiting
20
Shantou University Medical College Cancer Hospital
Shantou, China
Actively Recruiting
21
Liaoning Cancer Hospital
Shenyang, China
Actively Recruiting
22
Shanxi Cancer Hospital
Taiyuan, China
Actively Recruiting
23
Tianjin Medical University Cancer institute & Hospital
Tianjin, China
Actively Recruiting
24
Hubei Cancer Hospital
Wuhan, China
Actively Recruiting
25
Affiliated Hospital of Jiangnan University
Wuxi, China
Actively Recruiting
26
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Actively Recruiting
27
The First Affiliated Hospital of Xiamen University
Xiamen, China
Actively Recruiting
28
Xiangyang Central Hospital
Xiangyang, China
Actively Recruiting
29
Yantai Yuhuangding Hospital
Yantai, China
Actively Recruiting
30
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
J
Jianming Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here