Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT06132932
Eligibility Criteria:
Inclusion Criteria:
* 18-75 years of age
* Histologically or cytologically confirmed advanced malignant solid tumors (excluding non-small cell lung cancer) who have failed standard treatment, have no standard treatment options, or for whom standard treatment is not suitable at the current stage (colorectal cancer patients must provide genetic test results confirming KRAS wild-type)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Life expectancy of more than 3 months
* At least one measurable lesion according to RECIST 1.1
* Adequate organic function
* Signed and dated informed consent
Exclusion Criteria:
* Anti-tumor treatments such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy received within 4 weeks before the first use of the study drug
* Other unapproved clinical trial drugs or treatments received within 4 weeks before the first use of the study drug
* Major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first use of the study drug
* Systemic use of corticosteroids or other immunosuppressive agents within 14 days before the first use of the study drug
* Previous treatment with PI3K, AKT, or mTOR inhibitors
* Active infection requiring systemic anti-infection treatment
* Known alcohol or drug dependence
* Individuals with mental disorders or poor compliance
* Pregnant or lactating women
* The researcher believes that the subject has other serious systemic medical history or other reasons that make them unsuitable for participating in this clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06132932
Study Brief:
Protocol Section:
NCT06132932