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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04643405
Other study ID # APG1387PC101
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 17, 2021
Est. completion date December 1, 2024

Study information

Verified date September 2023
Source Ascentage Pharma Group Inc.
Contact Xianjun Yu, MD
Phone +86-21-64175590
Email yuxianjun@fudanpci.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date December 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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 TNFa 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.

Study Design


Intervention

Drug:
APG-1387 for Injection
APG1387 will be administered IV days 1, 8, 15 and 22 of a 28 day cycle.
Gemcitabine
Gemcitabine 1000 mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.
Nab paclitaxel
Nab-Paclitaxel 125mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.

Locations

Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ascentage Pharma Group Inc.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 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.
Secondary Duration of Response (DOR) From date of response until the date of progression. Up to 2 years.
Secondary Overall Survival (OS) From date of treatment start until the date of death due to any cause. Up to 2 years.
Secondary Maximum plasma concentration (Cmax) Cmax of APG-1387 and Nab-Paclitaxel will be assessed in the patients in this study. 28 days.
Secondary 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.
Secondary Adverse events Adverse events (AE) and serious adverse events (SAE) will be graded according to NCI CTCAE Version 5.0. Up to 2 years.
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