A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
Recruiting · NCT06434597 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
View the official record on ClinicalTrials.gov →Interventions studied
SPH5030
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 ≥ 3 months;
- No serious abnormalities in hematopoietic function, liver or kidney function;
- Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;
- Fully informed subjects who voluntarily sign the ICF.
Exclusion criteria
- Subjects who have previously received anti-HER2 molecular targeted therapy;
- Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;
- 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;
- 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.
Where it is running
30 locations listed.
- 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