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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT07068932
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years, any gender.
2. ECOG performance status 0-1.
3. Histologically or cytologically confirmed malignant tumor patients who have failed standard therapy, or are intolerant to standard therapy, or have no standard treatment available.
4. Adequate organ function.
5. Voluntary participation in this clinical trial, with full understanding of study procedures and ability to provide written informed consent.
6. Expected survival ≥12 weeks.
7. Patients in the dose-expansion phase must have measurable lesions.
8. Agreement to use contraception from the time of signing the informed consent to at least 60 days after the last dose of the investigational drug.
Exclusion Criteria:
1. Prior treatment with the same class of investigational drug.
2. Confirmed or suspected central nervous system (CNS) tumor involvement.
3. Uncontrolled tumor-related pain.
4. Active autoimmune disease, history of immunodeficiency (including primary or secondary, e.g., HIV infection), or autoimmune disorders requiring systemic therapy.
5. Clinically significant cardiovascular disease history.
6. Known hypersensitivity to any component of the investigational drug.
7. Major surgery or significant trauma within 4 weeks prior to the first dose of the investigational drug; diagnostic or superficial surgery within 7 days before the first dose; or planned major surgery during the study period.
8. Adverse events from prior therapy have not recovered to ≤ CTCAE Grade 1.
9. Severe infection within 4 weeks before the first dose, or active infection within 2 weeks.
10. History of cerebrovascular accident within 6 months before the first dose of the investigational drug.
11. Patients with other active malignancies within 2 years prior to the first dose or concurrent malignancies.
12. Patients with any other condition judged by the investigator that makes the patient unsuitable for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07068932
Study Brief:
Protocol Section:
NCT07068932