APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma

  • STATUS
    Recruiting
  • End date
    Dec 23, 2023
  • participants needed
    44
  • sponsor
    Ascentage Pharma Group Inc.
Updated on 23 March 2022

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.

Description

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.

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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note