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:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
NCT ID:
NCT06907628
Eligibility Criteria:
Inclusion Criteria:
1. Subjects with ability to understand and voluntarily agree to participate by giving written informed consent form for the study.
2. Patients with unresectable recurrent or metastatic solid tumors.
3. There is at least one lesion that could be measured.
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
5. Adequate organ functions as defined.
6. Life expectancy ≥ 3 months.
Exclusion Criteria:
1. Patients with known active central nervous system (CNS) metastases.
2. Subjects with other malignancy in five years before the first dose.
3. Patients with tumor-related pain that cannot be controlled as determined.
4. Patients with serious cardiovascular and cerebrovascular diseases.
5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
6. Patients with severe infections.
7. History of immunodeficiency.
8. History of autoimmune diseases.
9. Active infection.
10. Pregnant or nursing women.
11. Known history of serious allergic reactions to the investigational product or its main ingredients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06907628
Study Brief:
Protocol Section:
NCT06907628