APG-1387 Plus Chemotherapy In Advanced Pancreatic Adenocarcinoma

Study Overview

APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma

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.

Advanced Pancreatic Cancer

DRUG: APG-1387 for Injection
DRUG: Gemcitabine
DRUG: Nab paclitaxel

APG1387PC101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-11-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-08-13
First Submitted that Met QC Criteria 2020-11-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-08-14
First Posted (ACTUAL) 2020-11-25	Results First Posted N/A	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: APG1387 in combination with Gemcitabine and Nab-Paclitaxel	DRUG: APG-1387 for Injection APG1387 will be administered IV days 1， 8, 15 and 22 of a 28 day cycle. DRUG: Gemcitabine Gemcitabine 1000 mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle. DRUG: Nab paclitaxel Nab-Paclitaxel 125mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: APG1387 in combination with Gemcitabine and Nab-Paclitaxel

DRUG: APG-1387 for Injection

APG1387 will be administered IV days 1， 8, 15 and 22 of a 28 day cycle.

DRUG: Gemcitabine

Gemcitabine 1000 mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.

DRUG: Nab paclitaxel

Nab-Paclitaxel 125mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.

Primary Outcome Measures	Measure Description	Time Frame
Dose Limiting Toxicities (DLT) of combination therapy (Applicable for: phase Ib stage ).	DLT will be graded according to NCI CTCAE Version 5.0. DLT will be defined as clinically significant drug-related adverse events during the cycle one.	28 days.
Overall Response Rate (Applicable for: phase II stage) .	Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.	Up to 2 years.

Secondary Outcome Measures	Measure Description	Time Frame
Progression Free Survival (PFS)	From date of treatment start until the date of progression or the date of death due to any cause.	Up to 2 years.
Duration of Response (DOR)	From date of response until the date of progression.	Up to 2 years.
Overall Survival (OS)	From date of treatment start until the date of death due to any cause.	Up to 2 years.
Maximum plasma concentration (Cmax)	Cmax of APG-1387 and Nab-Paclitaxel will be assessed in the patients in this study.	28 days.
Area under the plasma concentration versus time curve (AUC)	AUC of APG-1387 and Nab-Paclitaxel will be assessed in the patients in this study.	28 days.
Adverse events	Adverse events (AE) and serious adverse events (SAE) will be graded according to NCI CTCAE Version 5.0.	Up to 2 years.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xianjun Yu, MD

Phone Number: +86-21-64175590

Email: yuxianjun@fudanpci.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Yifan Zhai, MD, PhD, Jiangsu Ascentage Pharma Co., Ltd.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record