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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT05740202
Eligibility Criteria:
Inclusion Criteria:
1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;
3. Histopathologically or cytologically documented advanced or metastatic malignancies;
4. At least 1 measurable lesion conforming to RECIST 1.1 criteria;
5. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
6. Female and male patients of reproductive potential must agree to use highly effective contraception.
Exclusion Criteria:
1. Any immunostimulants administered within 4 weeks;
2. Systemic anti-tumor therapy within 4 weeks;
3. Any investigational cancer therapy administered within 4 weeks;
4. Surgical procedures requiring general anesthesia within 4 weeks;
5. History of autoimmune diseases;
6. History of immunodeficiency;
7. Severe infections within 2 weeks prior to the first study treatment;
8. Clinically significant cardiovascular condition;
9. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
10. 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:
NCT05740202
Study Brief:
Protocol Section:
NCT05740202