Biliary Tract or Colorectal Cancer With Her2-positive/Mutated
Conditions
Brief summary
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
Interventions
DRUGSPH5030
SPH5030：Oral, QD, 600mg
Sponsors
Shanghai Pharmaceuticals Holding Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactJianming Xu
Outcome results
None listed