A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
- Conditions
- Biliary Tract or Colorectal Cancer With Her2-positive/Mutated
- Interventions
- Registration Number
- NCT06434597
- Lead Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Brief Summary
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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;
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SPH5030 SPH5030 -
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Approximately 2 years Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
- Secondary Outcome Measures
Name Time Method Duration of remission (DOR) Approximately 2 years DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.
Disease control rate (DCR) Approximately 2 years DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
Progression-free survival (PFS) Approximately 2 years From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Overall Survival (OS) Approximately 2 years Determination of the overall survival times of all patients
Incidence of Treatment-Emergent Adverse Events Approximately 2 years Adverse event type, incidence, duration
Trial Locations
- Locations (30)
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