An Open Label, Multiple Centers Phase Ib/II Study of APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma

Trial ID: NCT04643405

Interventional - Phase 1/2 - Terminated

This study is a two stage study consisting of a dose escalation phase Ib and a phase II study which include subjects with previously-treated, advanced pancreatic adenocarcinoma. Dose Limiting Toxicities (DLTs) and maximum tolerated dose (MTD) of APG1387 in combination with nab-paclitaxel and gemcitabine will be evaluated in the dose escalation phase Ib. Safety and efficacy of APG1387 plus gemcitabine and nab-paclitaxel will be evaluated in phase II.

Conditions

• Advanced Pancreatic Cancer

Interventions

• APG-1387 for Injection
• Gemcitabine
• Nab paclitaxel

Eligibility

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.

Sponsor

Ascentage Pharma Group Inc.

Source: ClinicalTrials.gov

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