APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma

Launched by ASCENTAGE PHARMA GROUP INC. · Nov 19, 2020

Keywords

ClinConnect Summary

**Summary of the Clinical Trial: APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma**

This clinical trial is exploring a new treatment for advanced pancreatic cancer, specifically looking at a combination of a drug called APG-1387 with two standard chemotherapy medications, nab-paclitaxel and gemcitabine. The study is divided into two parts: the first part will determine the highest dose of APG-1387 that can be safely given to patients, while the second part will evaluate how effective this combination is in treating the cancer. The trial is currently recruiting participants who are at least 18 years old and have advanced pancreatic cancer that has not responded well to previous treatments.

To be eligible for this study, participants should be in reasonably good health, with a life expectancy of at least three months and have measurable cancer that can be tracked using imaging tests. However, there are some important exclusions; for example, individuals who have recently undergone certain treatments or surgeries, or those with specific infections or conditions, may not qualify. Participants in the trial will receive careful monitoring and support throughout the study. This trial offers a chance to access a potentially new treatment option while contributing to valuable research that may help improve care for future patients with pancreatic cancer.

Gender

ALL

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.