APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
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- STATUS
- Recruiting
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- End date
- Dec 23, 2023
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- participants needed
- 44
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- sponsor
- Ascentage Pharma Group Inc.
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 Identifier | NCT04643405 |
| Sponsor | Ascentage Pharma Group Inc. |
| Last Modified on | 23 March 2022 |
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