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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT05048160
Eligibility Criteria:
Inclusion Criteria:
* 1\. Men or women, age ≥18.
* 2.Subjects with advanced malignancy histopathologically and/or cytologically, with at least one evaluable tumor lesion.
* 3.ECOG PS is 0 or 1.
* 4.Survival expectation of at least 3 months.
* 5.Adequate organs and hematopoietic functions
* 6.Voluntarily signing of informed consent
Exclusion Criteria:
* 1.Subjects with brain metastases of clinically active central nervous system (CNS).
* 2.Subjects that require to take anticoagulants and/or aspirin.
* 3.Blood transfusion within 2 weeks prior to the first administration of study treatment.
* 4.Inadequately controlled body cavity effusions.
* 5.Subjects with active, or have a history and possible recurrence of autoimmune diseases .
* 6.Have uncontrolled systemic diseases.
* 7.Subjects who had received anticancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.
* 8.Subjects are known to have previously experienced severe allergic reactions to large molecular protein formulations/monoclonal antibodies.
* 9.Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05048160
Study Brief:
Protocol Section:
NCT05048160