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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT07192120
Eligibility Criteria:
Inclusion Criteria:
1. Voluntarily agrees to participate in the study and signs the informed consent form.
2. Age ≥ 18 years, no restriction on gender.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Estimated life expectancy ≥ 3 months.
5. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
6. At least one measurable lesion per RECIST v1.1 criteria or one bone.
7. Adequate bone marrow reserve and organ function. -
Exclusion Criteria:
1. History of ≥2 primary malignancies within 5 years prior to informed consent.
2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.
4. Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
5. Severe bone damage caused by bone metastasis of prostate cancer.
6. Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1.
7. Severe lung disease affecting pulmonary function.
8. Vaccinated within 4 weeks before dosing.
9. Active systemic infection requiring treatment within 7 days before dosing.
10. Serious cardiovascular or cerebrovascular diseases.
11. Uncontrolled third-space effusions not suitable for enrollment.
12. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
13. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
14. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
15. Known alcohol or drug dependence.
16. Pregnant or breastfeeding women, or individuals planning to conceive. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07192120
Study Brief:
Protocol Section:
NCT07192120