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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT04643405
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must be ≥18 years of age at time of informed consent
2. Able to comply with the study protocol, in the investigator's judgment
3. Expected survival ≥ 3 months
4. Histology or cytology confirmed as advanced pancreatic adenocarcinoma, and:
* Standard treatment failed or intolerant to standard treatment(Phase Ib);
* First line standard treatment failed (Phase II).
5. ECOG 0-1;
6. Adequate organ function.
7. Subjects must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment
Exclusion Criteria:
1. Has had chemotherapy, radiation, target or other antitumor therapy within 14 days prior to the first dose of study drug.
2. Has received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
3. Has received a therapy with TNFα within 28 days of the first dose of study drug.
4. Known active central nervous system involvement.
5. Has received IAP-inhibitor before.
6. Has had major surgery within 28 days of dosing of investigational agent, or minor surgery within 14 days.
7. Patients with clinically evident Hepatitis B surface antigen (HBs) positive, Hepatitis C virus (HCV) antibody positive, Human Immunodeficiency Virus (HIV) antibody positive.
8. Pregnant or breastfeeding (lactating) women.
9. Other situations that investigator think not suit for study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04643405
Study Brief:
Protocol Section:
NCT04643405