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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT03544905
Eligibility Criteria:
Inclusion Criteria:
* main inclusion:
1. Evidence of a personally signed informed consent document;
2. Male and/or female subjects above the ages of 18 years;
3. Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a;
4. Subject may provide Tumor tissue section(at least 8 pieces) if they agree;
5. ECOG performance score 0-1;
6. Life expectancy ≥ 12 weeks;
7. At least 1 measurable target lesion on the baseline scan as per RECIST 1.1
Exclusion Criteria:
* main criteria:
1. prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment;
2. Prior or concomitant other malignant tumor;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03544905
Study Brief:
Protocol Section:
NCT03544905