A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.

Launched by SHANGHAI PHARMACEUTICALS HOLDING CO., LTD · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SPH5030 tablets for patients with specific types of cancer, namely biliary tract cancer or colorectal cancer that is HER2-positive or has a HER2 gene mutation. The main goal of the trial is to see how effective and safe this medication is for people who have advanced stages of these cancers, which means their cancer has spread or cannot be surgically removed.

To be eligible for the trial, participants need to have certain characteristics, including having advanced colorectal adenocarcinoma or biliary tract carcinoma that is either metastatic (spread to other parts of the body) or unresectable (unable to be surgically removed). They should also have a HER2-positive status or a mutation in the HER2 gene, and be in generally good health, with an expected survival of at least three months. Participants will be closely monitored throughout the study, and it's important that they meet specific health criteria to ensure their safety. If you or a loved one are considering joining this trial, it’s a chance to help further research in treating these types of cancer while receiving potential new treatment.

Gender

ALL

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.