A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
NCT ID: NCT06434597
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-07-17
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SPH5030
SPH5030
SPH5030：Oral, QD, 600mg
Interventions
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SPH5030
SPH5030：Oral, QD, 600mg
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Beijing Friendship Hospital，Capital Medical University
Beijing, , China
Chinese PLA General hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
The Second Affiliatedf Hospital of AFMU
Beijing, , China
XiangYa Hospital CentralSouth University
Changsha, , China
Changzhi People's Hospital
Changzhi, , China
Fujian Cancer Hospital
Fuzhou, , China
General Hospital of Fuzhou
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Anhui Provincial Cancer Hospital
Hefei, , China
Hengshui People's Hospital
Hengshui, , China
Yunnan Cancer Hospital
Kunming, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Shanghai General Hospital
Shanghai, , China
The Third Affiliated Hospital of Air Force Medical University
Shanghai, , China
Zhongshan Hospital
Shanghai, , China
Shantou University Medical College Cancer Hospital
Shantou, , China
Liaoning Cancer Hospital
Shenyang, , China
Shanxi Cancer Hospital
Taiyuan, , China
Tianjin Medical University Cancer institute & Hospital
Tianjin, , China
Hubei Cancer Hospital
Wuhan, , China
Affiliated Hospital of Jiangnan University
Wuxi, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Xiangyang Central Hospital
Xiangyang, , China
Yantai Yuhuangding Hospital
Yantai, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Bangwei Cao
Role: primary
Jianming Xu
Role: primary
Haitao Zhao
Role: primary
Haichuan Su
Role: primary
Xuejun Gong
Role: primary
Jie Ge
Role: backup
Jun Zhao
Role: primary
Jianwei Yang
Role: primary
Dongliang Li
Role: primary
Dong Ma
Role: primary
Hongming Pan
Role: primary
Haijun Zhong
Role: primary
Yanqiao Zhang
Role: primary
Yifu He
Role: primary
Daqing Wang
Role: primary
Yunfeng Li
Role: primary
Zhiyu Chen
Role: primary
Qi Li
Role: primary
Qian Zhang
Role: primary
Houbao Liu
Role: primary
Huichuan Sun
Role: backup
Yi Jiang
Role: primary
Jingdong Zhang
Role: primary
Wenhui Yang
Role: primary
Zhanyu Pan
Role: primary
Lei Nie
Role: primary
Gaoxiang
Role: primary
Enxiao Li
Role: primary
Weiwei Tang
Role: primary
Wei Gong
Role: primary
Jian Chen
Role: primary
Xiaobing Chen
Role: primary
Other Identifiers
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SPH5030-201
Identifier Type: -
Identifier Source: org_study_id
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