APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma

  • End date
    Dec 23, 2023
  • participants needed
  • sponsor
    Ascentage Pharma Group Inc.
Updated on 23 March 2022


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.


The ability of tumor cells to evade apoptosis is currently a major problem in anti-tumor therapy. IAPs are an important class of apoptosis-regulating proteins. APG-1387, a potent bivalent SMAC mimetic, small molecule of IAP inhibitor, which could inhibit pancreatic cancer proliferation as monotherapy and in combination with chemotherapy through apoptosis pathway.

It's an open label, multiple centers phase Ib/II Study. Safety and tolerability of APG1387 combined with nab-paclitaxel and gemcitabine will be evaluated in phase Ib in previously-treated, advanced pancreatic adenocarcinoma patients. Efficacy and tolerability will be evaluated in phase II study in first line standard treatment failed metastatic pancreatic adenocarcinoma patients.

Condition Advanced Pancreatic Cancer
Treatment Gemcitabine, APG-1387 for Injection, nab paclitaxel
Clinical Study IdentifierNCT04643405
SponsorAscentage Pharma Group Inc.
Last Modified on23 March 2022


Yes No Not Sure

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
Standard treatment failed or intolerant to standard treatment(Phase Ib)
First line standard treatment failed (Phase II)
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
Has received IAP-inhibitor before
Known active central nervous system involvement
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
Other situations that investigator think not suit for study
Pregnant or breastfeeding (lactating) women
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