Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)

Phase 1/2 Completed 29 enrolled Silence Therapeutics GmbH FGK Clinical Research GmbH · collab Granzer Regulatory Consulting & Services · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate a new treatment strategy for advanced pancreatic cancer disease by combining the new investigational medicinal product Atu027 with the standard chemotherapeutic gemcitabine. This combination aims at enhancing gemcitabine´s anti-tumor activity with Atu027. The objectives of this clinical trial are to evaluate safety and activity of two Atu027 schedules in combination with standard gemcitabine treatment in patients with advanced or metastatic pancreatic adenocarcinoma.

Timeline

Start: 2013-03
Primary completion: 2015-08
Completion: 2016-01

Outcome

Met primary endpoint

release “In addition, we have successfully completed our Atu027 Phase 2a pancreatic cancer tri al, meeting its primary endpoint.” silence-therapeutics.com ↗

Publications

Schultheis B, Strumberg D, Kuhlmann J, Wolf M, Link K, Seufferlein T, Kaufmann J, Feist M, Gebhardt F, Khan M, Stintzing S, Pelzer U. Safety, Efficacy and Pharcacokinetics of Targeted Therapy with The Liposomal RNA Interference Therapeutic Atu027 Combined with Gemcitabine in Patients with Pancreatic Adenocarcinoma. A Randomized Phase Ib/IIa Study. Cancers (Basel). 2020 Oct 26;12(11):3130. doi: 10.3390/cancers12113130.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atu027	Small interfering RNA (siRNA)	0.235 mg/kg	—
Background	Gemcitabine	Small molecule	—	—