Clinical trial NCT06434597: A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
Official title: A Multicenter, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH5030 Tablets in Subjects With Her2-positive/Mutated Biliary Tract OR Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Biliary Tract or Colorectal Cancer With Her2-positive/Mutated
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.


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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Duration of remission (DOR)
timeFrame: Approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Approximately 2 years
measure: Progression-free survival (PFS)
timeFrame: Approximately 2 years
measure: Overall Survival (OS)
timeFrame: Approximately 2 years
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital，Capital Medical University
city: Beijing
country: China
facility: Chinese PLA General hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: The Second Affiliatedf Hospital of AFMU
city: Changsha
country: China
facility: XiangYa Hospital CentralSouth University
city: Changzhi
country: China
facility: Changzhi People's Hospital
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Fuzhou
country: China
facility: General Hospital of Fuzhou
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
city: Hengshui
country: China
facility: Hengshui People's Hospital
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shanghai
country: China
facility: The Third Affiliated Hospital of Air Force Medical University
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Shantou
country: China
facility: Shantou University Medical College Cancer Hospital
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer institute & Hospital
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References: