RecruitingPhase 2NCT06434597
A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
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.
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Enrollment
60 participants
Start Date
Jul 17, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria4
- 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.
Interventions
DRUGSPH5030
SPH5030：Oral, QD, 600mg
Locations(30)
View Full Details on ClinicalTrials.gov
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NCT06434597