APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma (NCT04643405) | Clinical Trial Compass
TerminatedPhase 1/2
APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
Stopped: Company Strategy
China21 participantsStarted 2021-03-17
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must be ≥18 years of age at time of informed consent
✓. Able to comply with the study protocol, in the investigator's judgment
✓. Expected survival ≥ 3 months
✓. Histology or cytology confirmed as advanced pancreatic adenocarcinoma, and:
✓. ECOG 0-1;
✓. Adequate organ function.
✓. Subjects must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment
Exclusion criteria
✕. Has had chemotherapy, radiation, target or other antitumor therapy within 14 days prior to the first dose of study drug.
✕. Has received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
✕. Has received a therapy with TNFα within 28 days of the first dose of study drug.
✕. Known active central nervous system involvement.
✕. Has received IAP-inhibitor before.
✕. Has had major surgery within 28 days of dosing of investigational agent, or minor surgery within 14 days.
✕. Patients with clinically evident Hepatitis B surface antigen (HBs) positive, Hepatitis C virus (HCV) antibody positive, Human Immunodeficiency Virus (HIV) antibody positive.