NCT04643405

APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma

An Open Label, Multiple Centers Phase Ib/II Study of APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-17
• Primary completion: 2024-06-25
• Completion: 2024-12-10
• First posted: 2020-11-25
• Last updated: 2026-01-08

Locations

1 site across 1 country: China